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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92466

52 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 18, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

52 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 52

Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures

Z-2154-2023
Recall number
Z-2154-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
1,505,262 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 May 2023: Model Number (GTIN Number): DYNJE5900 (Each: 10884389114124, Case: 40884389114125), DYNJE5910 (Each: 10884389114094, Case: 40884389114095), DYNJE5920 (Each: 10884389114100, Case: 40884389114101), DYNJE5930 (Each: 10884389114117, Case: 40884389114118), DYNJE5940 (Each: 10888277723641, Case: 20888277723648), DYNJEX5900 (Each: 10884389114124, Case: 40884389114125). All lots within their expiration date.

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 2 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476

Z-2155-2023
Recall number
Z-2155-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: UDI/DI (EA) 10193489571998, UDI/DI (CS) 40193489571999

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 3 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1847; j) ANESTHESIA BLOCK PACK - TBR, Model Number DYNJRA1864; k) 18G CPNB 20G STYLETED CATHETER, Model Number DYNJRA1869; l) NERVE BLOCK TRAY, Model Number DYNJRA1878; m) BLOCK KIT, Model Number DYNJRA1893; n) NERVE BLOCK TRAY, Model Number DYNJRA1900; o) US TPI KIT, Model Number DYNJRA1945; p) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1975; q) DR LEWIS US TRAY, Model Number DYNJRA1998; r) ULTRASOUND GUIDED NERVE BLOCK, Model Number DYNJRA2013; s) ULTRASOUND TRAY, Model Number DYNJRA2022; t) NERVE BLOCK INSERTION, Model Number DYNJRA2027; u) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028; v) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028A; w) PAIN TRAY, Model Number DYNJRA2041; x) SUPPORT TRAY, Model Number DYNJRA2044; y) SUPERFICIAL NERVE BLOCK, Model Number DYNJRA2086; z) NERVE BLOCK TRAY, Model Number DYNJRA2148; aa) TRAY 18G CPNB 20G STYLETED, Model Number DYNJRA9040; bb) ULTRASOUND BLOCK TRAY, Model Number DYNJRA9044; cc) PERIPHERAL NERVE CATHETER KT, Model Number PAIN1560; dd) PAIN PREP W/PROBE COVER TRAY, Model Number PAIN1762

Z-2156-2023
Recall number
Z-2156-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
28568 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 1 May 2023: a) Model Number DYNJ81722, UDI/DI (EA) 10195327136437, UDI/DI (CS)40195327136438; b) Model Number DYNJRA0827A, UDI/DI (EA) 10193489214468, UDI/DI (CS)40193489214469; c) Model Number DYNJRA0881, UDI/DI (EA) 10889942463930, UDI/DI (CS)40889942463931; d) Model Number DYNJRA0881A, UDI/DI (EA) 10195327262402, UDI/DI (CS)40195327262403; e) Model Number DYNJRA1603, UDI/DI (EA) 10193489299007, UDI/DI (CS)40193489299008; f) Model Number DYNJRA1739A, UDI/DI (EA) 10193489924954, UDI/DI (CS)40193489924955; g) Model Number DYNJRA1823, UDI/DI (EA) 10193489961881, UDI/DI (CS)40193489961882; h) Model Number DYNJRA1837, UDI/DI (EA) 10193489976717, UDI/DI (CS)40193489976718; i) Model Number DYNJRA1847, UDI/DI (EA) 10193489993660, UDI/DI (CS)40193489993661; j) Model Number DYNJRA1864, UDI/DI (EA) 10195327008789, UDI/DI (CS)40195327008780; k) Model Number DYNJRA1869, UDI/DI (EA) 10195327018818, UDI/DI (CS)40195327018819; l) Model Number DYNJRA1878, UDI/DI (EA) 10195327040376, UDI/DI (CS)40195327040377; m) Model Number DYNJRA1893, UDI/DI (EA) 10195327062828, UDI/DI (CS)40195327062829; n) Model Number DYNJRA1900, UDI/DI (EA) 10195327082253, UDI/DI (CS)40195327082254; o) Model Number DYNJRA1945, UDI/DI (EA) 10195327133054, UDI/DI (CS)40195327133055; p) Model Number DYNJRA1975, UDI/DI (EA) 10195327163242, UDI/DI (CS)40195327163243; q) Model Number DYNJRA1998, UDI/DI (EA) 10195327194291, UDI/DI (CS)40195327194292; r) Model Number DYNJRA2013, UDI/DI (EA) 10195327212049, UDI/DI (CS)40195327212040; s) Model Number DYNJRA2022, UDI/DI (EA) 10195327218164, UDI/DI (CS)40195327218165; t) Model Number DYNJRA2027, UDI/DI (EA) 10195327225223, UDI/DI (CS)40195327225224; u) Model Number DYNJRA2028, UDI/DI (EA) 10195327226299, UDI/DI (CS)40195327226290; v) Model Number DYNJRA2028A, UDI/DI (EA) 10195327352042, UDI/DI (CS)40195327352043; w) Model Number DYNJRA2041, UDI/DI (EA) 10195327243708, UDI/DI (CS)40195327243709; x) Model Number DYNJRA2044, UDI/DI (EA) 10195327247300, UDI/DI (CS)40195327247301; y) Model Number DYNJRA2086, UDI/DI (EA) 10195327286750, UDI/DI (CS)40195327286751; z) Model Number DYNJRA2148, UDI/DI (EA) 10195327363758, UDI/DI (CS)40195327363759; aa) Model Number DYNJRA9040, UDI/DI (EA) 10193489830514, UDI/DI (CS)40193489830515; bb) Model Number DYNJRA9044, UDI/DI (EA) 10193489888119, UDI/DI (CS)40193489888110; cc) Model Number PAIN1560, UDI/DI (EA) 10193489215380, UDI/DI (CS)40193489215381; dd) Model Number PAIN1762, UDI/DI (EA) 10193489962093, UDI/DI (CS)40193489962094;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 4 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A

Z-2157-2023
Recall number
Z-2157-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: UDI/DI (EA) 10888277507210, UDI/DI (CS) 40888277507211

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 5 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;

Z-2158-2023
Recall number
Z-2158-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
23938 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1220, UDI/DI (EA)10888277795037, UDI/DI (CS)40888277795038; b) Model Number DYNJRA1773, UDI/DI (EA)10193489862973, UDI/DI (CS)40193489862974; c) Model Number DYNJ51107B, UDI/DI (EA)10193489810479, UDI/DI (CS)40193489810470; d) Model Number DYNJ0703127A, UDI/DI (EA)10889942084630, UDI/DI (CS)40889942084631; e) Model Number DYNJ42367B, UDI/DI (EA)10193489211511, UDI/DI (CS)40193489211512; f) Model Number DYNJRA1571, UDI/DI (EA)10193489264739, UDI/DI (CS)40193489264730; g) Model Number DYNJRA0656A, UDI/DI (EA)10889942225118, UDI/DI (CS)40889942225119; h) Model Number DYNJ47338, UDI/DI (EA)10888277900172, UDI/DI (CS)40888277900173; i) Model Number DYNJRA1287A, UDI/DI (EA)10193489773095, UDI/DI (CS)40193489773096; j) Model Number PAIN1622A, UDI/DI (EA)10193489891690, UDI/DI (CS)40193489891691; k) Model Number DYNJRA1543, UDI/DI (EA)10193489217667, UDI/DI (CS)40193489217668; l) Model Number DYNJRA1635A, UDI/DI (EA)10193489367645, UDI/DI (CS)40193489367646; m) Model Number DYNJ0134147D, UDI/DI (EA)10889942937349, UDI/DI (CS)40889942937340; n) Model Number DYNJRA1604, UDI/DI (EA)10193489299816, UDI/DI (CS)40193489299817; o) Model Number PAIN1182, UDI/DI (EA)10889942720927, UDI/DI (CS)40889942720928;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 6 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D; e) VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG; f) ANGIO PACK-LF, Model Number DYNJ0373279M; g) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I; h) IPMC ANGIOGRAPHY PACK-LF, Model Number DYNJ0806254D; i) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485T; j) ANGIO DRAPE PACK, Model Number DYNJ17624B; k) DEPAUL ANGIO PACK, Model Number DYNJ19939M; l) EP ANGIOGRAPHY PACK, Model Number DYNJ24225K; m) ANGIOGRAPHY DRAPE PACK-LF, Model Number DYNJ28067G; n) DASHTI-YAO NEURO ANGIO-LF, Model Number DYNJ33457C; o) ANGIOGRAM TRAY, Model Number DYNJ33638K; p) ANGIO PACK, Model Number DYNJ34361; q) ANGIO/PICC PACK, Model Number DYNJ36049; r) IR MINOR ANGIO PACK, Model Number DYNJ37665B; s) ANGIO LEFT HEART PACK, Model Number DYNJ40632C; t) MV-IR ANGIO DRAPE PACK-LF, Model Number DYNJ41553D; u) CUSTOM ANGIO TRAY, Model Number DYNJ41649F; v) FS ANGIO, Model Number DYNJ42499C; w) ANGIO PACK, Model Number DYNJ42903B; x) ANGIO PACK, Model Number DYNJ43661B; y) ANGIOGRAPHY PACK, Model Number DYNJ44293D; z) ANGIO DRAPE PACK, Model Number DYNJ44320F; aa) ANGIOGRAM PACK, Model Number DYNJ45007; bb) ANGIO BASIN SET, Model Number DYNJ46043F; cc) ANGIO TRAY, Model Number DYNJ46153B; dd) ANGIOGRAM PACK, Model Number DYNJ47004C; ee) ANGIO PACK, Model Number DYNJ47226A; ff) ANGIOGRAPHY PACK, Model Number DYNJ47906; gg) ANGIO DRAPE SPEC PROC PACK-LF, Model Number DYNJ47951A; hh) MH HOOD CARDIAC ANGIO, Model Number DYNJ49884F; ii) ANGIO PACK, Model Number DYNJ50624A; jj) ANGIO PACK, Model Number DYNJ51239A; kk) ANGIO TRAY, Model Number DYNJ52121; ll) ANGIO PACK-LF, Model Number DYNJ52898C; mm) ANGIOGRAPHY PACK, Model Number DYNJ55252B; nn) ANGIOGRAPHY PACK, Model Number DYNJ57498; oo) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645B; pp) GENERAL ANGIO PACK, Model Number DYNJ57760B; qq) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792A; rr) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792B; ss) ANGIO PACK, Model Number DYNJ58126A; tt) HH ANGIO PACK, Model Number DYNJ59465B; uu) OR ANGIO PACK, Model Number DYNJ60319A; vv) ANGIO PACK 2-A, Model Number DYNJ60507A; ww) FEMORAL ANGIOGRAPY SET UP, Model Number DYNJ61015B; xx) ANGIO PACK, Model Number DYNJ62299; yy) CLOVIS CATH LAB PACK, Model Number DYNJ62379; zz) ANGIO PACK, Model Number DYNJ62544; aaa) ANGIO TRAY W/CHLORAPREP, Model Number DYNJ62742; bbb) OR ANGIO PAC , Model Number DYNJ63976A; ccc) SUNSHINE PAC , Model Number DYNJ64830; ddd) ANGIO PAC , Model Number DYNJ65043A; eee) CATH LAB PAC , Model Number DYNJ65185; fff) ANGIOGRAPHY PACK, Model Number DYNJ65190C; ggg) PACK,BASIC ANGIO, Model Number DYNJ65482A; hhh) ANGIO PACK, Model Number DYNJ66398B; iii) ANGIOGRAPHY PACK, Model Number DYNJ66476; jjj) SURGERY ANGIO PACK-LF, Model Number DYNJ66500; kkk) OR ANGIOGRAPHY PACK, Model Number DYNJ67245; lll) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065A; mmm) ANGIO TRAY, Model Number DYNJ68758; nnn) ANGIO, Model Number DYNJ902507B; ooo) ANGIOGRAPHY PACK, Model Number DYNJC2371G; ppp) ANGIOGRAPHY DRAPE PACK, Model Number DYNJT2344B; qqq) PEDI ANGIO PACK-LF, Model Number PHS41743D

Z-2159-2023
Recall number
Z-2159-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
55014 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number 00-401318M, UDI/DI (EA)10193489348750, UDI/DI (CS)40193489348751 b) Model Number CDS984944C, UDI/DI (EA)10889942172955, UDI/DI (CS)40889942172956 c) Model Number DYNJ0149444M, UDI/DI (EA)10193489432824, UDI/DI (CS)40193489432825 d) Model Number DYNJ0160556D, UDI/DI (EA)10193489207552, UDI/DI (CS)40193489207553 e) Model Number DYNJ0201109AG, UDI/DI (EA)10193489497267, UDI/DI (CS)40193489497268 f) Model Number DYNJ0373279M, UDI/DI (EA)10193489519020, UDI/DI (CS)40193489519021 g) Model Number DYNJ0429121I, UDI/DI (EA)10193489897494, UDI/DI (CS)40193489897495 h) Model Number DYNJ0806254D, UDI/DI (EA)10889942471164, UDI/DI (CS)40889942471165 i) Model Number DYNJ0854485T, UDI/DI (EA)10193489864199, UDI/DI (CS)40193489864190 j) Model Number DYNJ17624B, UDI/DI (EA)10193489867299, UDI/DI (CS)40193489867290 k) Model Number DYNJ19939M, UDI/DI (EA)10193489393248, UDI/DI (CS)40193489393249 l) Model Number DYNJ24225K, UDI/DI (EA)10889942510702, UDI/DI (CS)40889942510703 m) Model Number DYNJ28067G, UDI/DI (EA)10889942744299, UDI/DI (CS)40889942744290 n) Model Number DYNJ33457C, UDI/DI (EA)10193489461800, UDI/DI (CS)40193489461801 o) Model Number DYNJ33638K, UDI/DI (EA)10193489343281, UDI/DI (CS)40193489343282 p) Model Number DYNJ34361, UDI/DI (EA)10884389348475, UDI/DI (CS)40884389348476 q) Model Number DYNJ36049, UDI/DI (EA)10884389498675, UDI/DI (CS)40884389498676 r) Model Number DYNJ37665B, UDI/DI (EA)10889942969739, UDI/DI (CS)40889942969730 s) Model Number DYNJ40632C, UDI/DI (EA)10193489461176, UDI/DI (CS)40193489461177 t) Model Number DYNJ41553D, UDI/DI (EA)10889942811335, UDI/DI (CS)40889942811336 u) Model Number DYNJ41649F, UDI/DI (EA)10193489641271, UDI/DI (CS)40193489641272 v) Model Number DYNJ42499C, UDI/DI (EA)10195327030865, UDI/DI (CS)40195327030866 w) Model Number DYNJ42903B, UDI/DI (EA)10888277798014, UDI/DI (CS)40888277798015 x) Model Number DYNJ43661B, UDI/DI (EA)10889942808700, UDI/DI (CS)40889942808701 y) Model Number DYNJ44293D, UDI/DI (EA)10193489833416, UDI/DI (CS)40193489833417 z) Model Number DYNJ44320F, UDI/DI (EA)10193489435511, UDI/DI (CS)40193489435512 aa) Model Number DYNJ45007, UDI/DI (EA)10888277085411, UDI/DI (CS)40888277085412 bb) Model Number DYNJ46043F, UDI/DI (EA)10193489856729, UDI/DI (CS)40193489856720 cc) Model Number DYNJ46153B, UDI/DI (EA)10193489853643, UDI/DI (CS)40193489853644 dd) Model Number DYNJ47004C, UDI/DI (EA)10193489696172, UDI/DI (CS)40193489696173 ee) Model Number DYNJ47226A, UDI/DI (EA)10888277561816, UDI/DI (CS)40888277561817 ff) Model Number DYNJ47906, UDI/DI (EA)10888277528376, UDI/DI (CS)40888277528377 gg) Model Number DYNJ47951A, UDI/DI (EA)10193489609844, UDI/DI (CS)40193489609845 hh) Model Number DYNJ49884F, UDI/DI (EA)10193489469578, UDI/DI (CS)40193489469579 ii) Model Number DYNJ50624A, UDI/DI (EA)10889942474639, UDI/DI (CS)40889942474630 jj) Model Number DYNJ51239A, UDI/DI (EA)10889942493548, UDI/DI (CS)40889942493549 kk) Model Number DYNJ52121, UDI/DI (EA)10889942243624, UDI/DI (CS)40889942243625 ll) Model Number DYNJ52898C, UDI/DI (EA)10193489876314, UDI/DI (CS)40193489876315 mm) Model Number DYNJ55252B, UDI/DI (EA)10193489870152, UDI/DI (CS)40193489870153 nn) Model Number DYNJ57498, UDI/DI (EA)10889942745746, UDI/DI (CS)40889942745747 oo) Model Number DYNJ57645B, UDI/DI (EA)10193489828658, UDI/DI (CS)40193489828659 pp) Model Number DYNJ57760B, UDI/DI (EA)10193489342581, UDI/DI (CS)40193489342582 qq) Model Number DYNJ57792A, UDI/DI (EA)10193489530896, UDI/DI (CS)40193489530897 rr) Model Number DYNJ57792B, UDI/DI (EA)10193489845945, UDI/DI (CS)40193489845946 ss) Model Number DYNJ58126A, UDI/DI (EA)10193489484755, UDI/DI (CS)40193489484756 tt) Model Number DYNJ59465B, UDI/DI (EA)10193489470932, UDI/DI (CS)40193489470933 uu) Model Number DYNJ60319A, UDI/DI (EA)10193489276299, UDI/DI (CS)40193489276290 vv) Model Number DYNJ60507A, UDI/DI (EA)10193489830552, UDI/DI (CS)40193489830553 ww) Model Number DYNJ61015B, UDI/DI (EA)10193489368888, UDI/DI (CS)40193489368889 xx) Model Number DYNJ62299, UDI/DI (EA)10193489641516, UDI/DI (CS)40193489641517 yy) Model Number DYNJ62379, UDI/DI (EA)10193489651706, UDI/DI (CS)40193489651707 zz) Model Number DYNJ62544, UDI/DI (EA)10193489666526, UDI/DI (CS)40193489666527 aaa) Model Number DYNJ62742, UDI/DI (EA)10193489685923, UDI/DI (CS)40193489685924 bbb) Model Number DYNJ63976A, UDI/DI (EA)10193489377965, UDI/DI (CS)40193489377966 ccc) Model Number DYNJ64830, UDI/DI (EA)10193489223132, UDI/DI (CS)40193489223133 ddd) Model Number DYNJ65043A, UDI/DI (EA)10193489379327, UDI/DI (CS)40193489379328 eee) Model Number DYNJ65185, UDI/DI (EA)10193489253146, UDI/DI (CS)40193489253147 fff) Model Number DYNJ65190C, UDI/DI (EA)10193489433111, UDI/DI (CS)40193489433112 ggg) Model Number DYNJ65482A, UDI/DI (EA)10193489416824, UDI/DI (CS)40193489416825 hhh) Model Number DYNJ66398B, UDI/DI (EA)10193489891928, UDI/DI (CS)40193489891929 iii) Model Number DYNJ66476, UDI/DI (EA)10193489356779, UDI/DI (CS)40193489356770 jjj) Model Number DYNJ66500, UDI/DI (EA)10193489357912, UDI/DI (CS)40193489357913 kkk) Model Number DYNJ67245, UDI/DI (EA)10193489393057, UDI/DI (CS)40193489393058 lll) Model Number DYNJ68065A, UDI/DI (EA)10193489888720, UDI/DI (CS)40193489888721 mmm) Model Number DYNJ68758, UDI/DI (EA)10193489837568, UDI/DI (CS)40193489837569 nnn) Model Number DYNJ902507B, UDI/DI (EA)10889942781188, UDI/DI (CS)40889942781189 ooo) Model Number DYNJC2371G, UDI/DI (EA)10889942494675, UDI/DI (CS)40889942494676 ppp) Model Number DYNJT2344B, UDI/DI (EA)10889942107803, UDI/DI (CS)40889942107804 qqq) Model Number PHS41743D, UDI/DI (EA)10193489453270, UDI/DI (CS)40193489453271

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 7 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Model Number DYNJ0407399P; l) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA; m) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K; n) CARDIAC EP PACK-LF, Model Number DYNJ0429185L; o) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C; p) LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG; q) CATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA; r) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R; s) CARDIAC CATH PACK-LF, Model Number DYNJ0842644F; t) PEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K; u) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V; v) CARDIAC CATH PACK-LF, Model Number DYNJ0855138P; w) CARDIAC CATH PACK-LF, Model Number DYNJ0855138Q; x) IR PICC PACK-LF, Model Number DYNJ0950839C; y) SPECIAL PROCEDURES, Model Number DYNJ23288C; z) ANGIO TRAY, Model Number DYNJ23438M; aa) ADULT CARDIAC CATH PACK, Model Number DYNJ23455K; bb) ADULT CARDIAC CATH PACK, Model Number DYNJ23455L; cc) ADULT CARDIAC CATH PACK, Model Number DYNJ23455M; dd) ADULT CARDIAC CATH PACK, Model Number DYNJ23455N; ee) STENT PACK-LF, Model Number DYNJ27613K; ff) CATH I W/ ANGIO DRAPE, Model Number DYNJ33709F; gg) JUGULAR PACK, Model Number DYNJ35164C; hh) ANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F; ii) ANGIO DRAPE II-LF, Model Number DYNJ35994C; jj) ANGIO/PICC PACK, Model Number DYNJ36049A; kk) ISSAQUA CATH/IR PACK, Model Number DYNJ36738G; ll) IR PACK, Model Number DYNJ36752B; mm) ARTERIOGRAM TRAY-LF, Model Number DYNJ36807C; nn) SPECIAL PROCEDURE PACK, Model Number DYNJ38314G; oo) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G; pp) CARDIAC CATH PACK, Model Number DYNJ38866F; qq) INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B; rr) ABLATION PACK, Model Number DYNJ40629C; ss) CATH LAB PACK, Model Number DYNJ40926A; tt) RADIOLOGY PACK, Model Number DYNJ41190; uu) TV IR PACK-LF, Model Number DYNJ41562F; vv) CUSTOM ANGIO TRAY, Model Number DYNJ41649G; ww) CARDIAC CATH DRAPE PACK, Model Number DYNJ41700A; xx) IR PACK, Model Number DYNJ41989G; yy) INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C; zz) ANGIO PACK, Model Number DYNJ42903C; aaa) ANGIO PACK, Model Number DYNJ42903D; bbb) CARDIAC CATH PACK-LF, Model Number DYNJ42996C; ccc) DIALYSIS TRAY, Model Number DYNJ43060B; ddd) ANGIOPLASTY PACK-LF, Model Number DYNJ43203G; eee) ARTERIOGRAM PACK, Model Number DYNJ43261J; fff) CATH LAB RIGHT HEART PACK, Model Number DYNJ43315L; ggg) ANGIO CATH COMBINED PACK, Model Number DYNJ43609P; hhh) ANGIO CATH COMBINED PACK, Model Number DYNJ43609R; iii) ANGIO CATH COMBINED PACK, Model Number DYNJ43609S; jjj) ANGIO PACK, Model Number DYNJ43661C; kkk) ABLATION EP PACK, Model Number DYNJ43851B; lll) PK, RADIOLOGY, Model Number DYNJ43894B; mmm) PK, RADIOLOGY, Model Number DYNJ44087A; nnn) ANGIOGRAPHY PACK, Model Number DYNJ44293F; ooo) ANGIO DRAPE PACK, Model Number DYNJ44320G; ppp) ANGIO DRAPE PACK, Model Number DYNJ44320I; qqq) ANGIO DRAPE PACK, Model Number DYNJ44320J; rrr) FEMORAL ANGIO PACK, Model Number DYNJ44334M; sss) FEMORAL ANGIO PACK, Model Number DYNJ44334N; ttt) RADIOLOGY PACK, Model Number DYNJ44524F; uuu) ANGIO PACK, Model Number DYNJ44642B; vvv) ANGIOPLASTY PACK, Model Number DYNJ44700J; www) ANGIO PACK, Model Number DYNJ44993J; xxx) ANGIOGRAPHY PACK, Model Number DYNJ45059B; yyy) PERCUTANEOUS PACK, Model Number D

Z-2160-2023
Recall number
Z-2160-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
173449 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017- May 2023: a) Model Number 00-400305R, UDI/DI (EA) 10193489944280, UDI/DI (CS) 40193489944281; b) Model Number DYNJ0037936C, UDI/DI (EA) 10195327031282, UDI/DI (CS) 40195327031283; c) Model Number DYNJ0037936D, UDI/DI (EA) 10195327129538, UDI/DI (CS) 40195327129539; d) Model Number DYNJ0149444N, UDI/DI (EA) 10193489966718, UDI/DI (CS) 40193489966719; e) Model Number DYNJ0198765G, UDI/DI (EA) 10889942053988, UDI/DI (CS) 40889942053989; f) Model Number DYNJ0275614F, UDI/DI (EA) 10889942174348, UDI/DI (CS) 40889942174349; g) Model Number DYNJ0290716M, UDI/DI (EA) 10195327088866, UDI/DI (CS) 40195327088867; h) Model Number DYNJ0313233V, UDI/DI (EA) 10889942247356, UDI/DI (CS) 40889942247357; i) Model Number DYNJ0313233W, UDI/DI (EA) 10195327110970, UDI/DI (CS) 40195327110971; j) Model Number DYNJ0313233X, UDI/DI (EA) 10195327250980, UDI/DI (CS) 40195327250981; k) Model Number DYNJ0407399P, UDI/DI (EA) 10195327336868, UDI/DI (CS) 40195327336869; l) Model Number DYNJ0416535AA, UDI/DI (EA) 10195327354596, UDI/DI (CS) 40195327354597; m) Model Number DYNJ0429121K, UDI/DI (EA) 10195327069506, UDI/DI (CS) 40195327069507; n) Model Number DYNJ0429185L, UDI/DI (EA) 10195327048976, UDI/DI (CS) 40195327048977; o) Model Number DYNJ0458661C, UDI/DI (EA) 10889942550944, UDI/DI (CS) 40889942550945; p) Model Number DYNJ0537652AG, UDI/DI (EA) 10195327017675, UDI/DI (CS) 40195327017676; q) Model Number DYNJ0545064AA, UDI/DI (EA) 10195327327385, UDI/DI (CS) 40195327327386; r) Model Number DYNJ0604508R, UDI/DI (EA) 10193489828443, UDI/DI (CS) 40193489828444; s) Model Number DYNJ0842644F, UDI/DI (EA) 10195327288600, UDI/DI (CS) 40195327288601; t) Model Number DYNJ0843244K, UDI/DI (EA) 10195327288594, UDI/DI (CS) 40195327288595; u) Model Number DYNJ0854485V, UDI/DI (EA) 10195327096885, UDI/DI (CS) 40195327096886; v) Model Number DYNJ0855138P, UDI/DI (EA) 10193489885132, UDI/DI (CS) 40193489885133; w) Model Number DYNJ0855138Q, UDI/DI (EA) 10195327094843, UDI/DI (CS) 40195327094844; x) Model Number DYNJ0950839C, UDI/DI (EA) 10889942101290, UDI/DI (CS) 40889942101291; y) Model Number DYNJ23288C, UDI/DI (EA) 10193489954142, UDI/DI (CS) 40193489954143; z) Model Number DYNJ23438M, UDI/DI (EA) 10193489970609, UDI/DI (CS) 40193489970600; aa) Model Number DYNJ23455K, UDI/DI (EA) 10193489446296, UDI/DI (CS) 40193489446297; bb) Model Number DYNJ23455L, UDI/DI (EA) 10193489977387, UDI/DI (CS) 40193489977388; cc) Model Number DYNJ23455M, UDI/DI (EA) 10195327129835, UDI/DI (CS) 40195327129836; dd) Model Number DYNJ23455N, UDI/DI (EA) 10195327237752, UDI/DI (CS) 40195327237753; ee) Model Number DYNJ27613K, UDI/DI (EA) 10195327131180, UDI/DI (CS) 40195327131181; ff) Model Number DYNJ33709F, UDI/DI (EA) 10889942713929, UDI/DI (CS) 40889942713920; gg) Model Number DYNJ35164C, UDI/DI (EA) 10889942494668, UDI/DI (CS) 40889942494669; hh) Model Number DYNJ35993F, UDI/DI (EA) 10195327398286, UDI/DI (CS) 40195327398287; ii) Model Number DYNJ35994C, UDI/DI (EA) 10195327397951, UDI/DI (CS) 40195327397952; jj) Model Number DYNJ36049A, UDI/DI (EA) 10195327147204, UDI/DI (CS) 40195327147205; kk) Model Number DYNJ36738G, UDI/DI (EA) 10195327054168, UDI/DI (CS) 40195327054169; ll) Model Number DYNJ36752B, UDI/DI (EA) 10195327226022, UDI/DI (CS) 40195327226023; mm) Model Number DYNJ36807C, UDI/DI (EA) 10195327082222, UDI/DI (CS) 40195327082223; nn) Model Number DYNJ38314G, UDI/DI (EA) 10193489603347, UDI/DI (CS) 40193489603348; oo) Model Number DYNJ38326G, UDI/DI (EA) 10195327230135, UDI/DI (CS) 40195327230136; pp) Model Number DYNJ38866F, UDI/DI (EA) 10193489914863, UDI/DI (CS) 40193489914864; qq) Model Number DYNJ40215B, UDI/DI (EA) 10888277912267, UDI/DI (CS) 40888277912268; rr) Model Number DYNJ40629C, UDI/DI (EA) 10193489997316, UDI/DI (CS) 40193489997317; ss) Model Number DYNJ40926A, UDI/DI (EA) 10195327137212, UDI/DI (CS) 40195327137213; tt) Model Number DYNJ41190, UDI/DI (EA) 10884389899083, UDI/DI (CS) 40884389899084; uu) Model Number DYNJ41562F, UDI/DI (EA) 10193489641080, UDI/DI (CS) 40193489641081; vv) Model Number DYNJ41649G, UDI/DI (EA) 10195327277291, UDI/DI (CS) 40195327277292; ww) Model Number DYNJ41700A, UDI/DI (EA) 10889942756957, UDI/DI (CS) 40889942756958; xx) Model Number DYNJ41989G, UDI/DI (EA) 10193489310801, UDI/DI (CS) 40193489310802; yy) Model Number DYNJ42231C, UDI/DI (EA) 10195327026561, UDI/DI (CS) 40195327026562; zz) Model Number DYNJ42903C, UDI/DI (EA) 10195327079666, UDI/DI (CS) 40195327079667; aaa) Model Number DYNJ42903D, UDI/DI (EA) 10195327171117, UDI/DI (CS) 40195327171118; bbb) Model Number DYNJ42996C, UDI/DI (EA) 10193489988437, UDI/DI (CS) 40193489988438; ccc) Model Number DYNJ43060B, UDI/DI (EA) 10889942765850, UDI/DI (CS) 40889942765851; ddd) Model Number DYNJ43203G, UDI/DI (EA) 10193489952919, UDI/DI (CS) 40193489952910; eee) Model Number DYNJ43261J, UDI/DI (EA) 10195327288792, UDI/DI (CS) 40195327288793; fff) Model Number DYNJ43315L, UDI/DI (EA) 10193489463675, UDI/DI (CS) 40193489463676; ggg) Model Number DYNJ43609P, UDI/DI (EA) 10193489914535, UDI/DI (CS) 40193489914536; hhh) Model Number DYNJ43609R, UDI/DI (EA) 10195327228781, UDI/DI (CS) 40195327228782; iii) Model Number DYNJ43609S, UDI/DI (EA) 10195327322984, UDI/DI (CS) 40195327322985; jjj) Model Number DYNJ43661C, UDI/DI (EA) 10195327104351, UDI/DI (CS) 40195327104352; kkk) Model Number DYNJ43851B, UDI/DI (EA) 10195327200329, UDI/DI (CS) 40195327200320; lll) Model Number DYNJ43894B, UDI/DI (EA) 10193489810486, UDI/DI (CS) 40193489810487; mmm) Model Number DYNJ44087A, UDI/DI (EA) 10889942561803, UDI/DI (CS) 40889942561804; nnn) Model Number DYNJ44293F, UDI/DI (EA) 10195327265182, UDI/DI (CS) 40195327265183; ooo) Model Number DYNJ44320G, UDI/DI (EA) 10193489966305, UDI/DI (CS) 40193489966306; ppp) Model Number DYNJ44320I, UDI/DI (EA) 10195327070359, UDI/DI (CS) 40195327070350; qqq) Model Number DYNJ44320J, UDI/DI (EA) 10195327132354, UDI/DI (CS) 40195327132355; rrr) Model Number DYNJ44334M, UDI/DI (EA) 10195327133115, UDI/DI (CS) 40195327133116; sss) Model Number DYNJ44334N, UDI/DI (EA) 10195327299491, UDI/DI (CS) 40195327299492; ttt) Model Number DYNJ44524F, UDI/DI (EA) 10193489467482, UDI/DI (CS) 40193489467483; uuu) Model Number DYNJ44642B, UDI/DI (EA) 10195327011420, UDI/DI (CS) 40195327011421; vvv) Model Number DYNJ44700J, UDI/DI (EA) 10195327277413, UDI/DI (CS) 40195327277414; www) Model Number DYNJ44993J, UDI/DI (EA) 10195327380922, UDI/DI (CS) 40195327380923; xxx) Model Number DYNJ45059B, UDI/DI (EA) 10889942135639, UDI/DI (CS) 40889942135630; yyy) Model Number DYNJ46035D, UDI/DI (EA) 10193489493641, UDI/DI (CS) 40193489493642; zzz) Model Number DYNJ46545B, UDI/DI (EA) 10195327008246, UDI/DI (CS) 40195327008247; aaaa) Model Number DYNJ46545C, UDI/DI (EA) 10195327250423, UDI/DI (CS) 40195327250424; bbbb) Model Number DYNJ47645B, UDI/DI (EA) 10193489952834, UDI/DI (CS) 40193489952835; cccc) Model Number DYNJ47646D, UDI/DI (EA) 10193489950472, UDI/DI (CS) 40193489950473; dddd) Model Number DYNJ47646F, UDI/DI (EA) 10195327155513, UDI/DI (CS) 40195327155514; eeee) Model Number DYNJ47646G, UDI/DI (EA) 10195327175023, UDI/DI (CS) 40195327175024; ffff) Model Number DYNJ47646I, UDI/DI (EA) 10195327357122, UDI/DI (CS) 40195327357123; gggg) Model Number DYNJ47665D, UDI/DI (EA) 10193489952827, UDI/DI (CS) 40193489952828; hhhh) Model Number DYNJ47665F, UDI/DI (EA) 10195327355210, UDI/DI (CS) 40195327355211; iiii) Model Number DYNJ49621C, UDI/DI (EA) 10195327008581, UDI/DI (CS) 40195327008582; jjjj) Model Number DYNJ50694A, UDI/DI (EA) 10889942693511, UDI/DI (CS) 40889942693512; kkkk) Model Number DYNJ50712D, UDI/DI (EA) 10195327267926, UDI/DI (CS) 40195327267927; llll) Model Number DYNJ51109B, UDI/DI (EA) 10889942456314, UDI/DI (CS) 40889942456315; mmmm) Model Number DYNJ51240A, UDI/DI (EA) 10889942493524, UDI/DI (CS) 40889942493525; nnnn) Model Number DYNJ51338C, UDI/DI (EA) 10193489241716, UDI/DI (CS) 40193489241717; oooo) Model Number DYNJ52000B, UDI/DI (EA) 10193489384987, UDI/DI (CS) 40193489384988; pppp) Model Number DYNJ52121A, UDI/DI (EA) 10195327260095, UDI/DI (CS) 40195327260096; qqqq) Model Number DYNJ52425J, UDI/DI (EA) 10193489940145, UDI/DI (CS) 40193489940146; rrrr) Model Number DYNJ52425K, UDI/DI (EA) 10195327042356, UDI/DI (CS) 40195327042357; ssss) Model Number DYNJ52425L, UDI/DI (EA) 10195327074487, UDI/DI (CS) 40195327074488; tttt) Model Number DYNJ52425M, UDI/DI (EA) 10195327177188, UDI/DI (CS) 40195327177189; uuuu) Model Number DYNJ52425N, UDI/DI (EA) 10195327339326, UDI/DI (CS) 40195327339327; vvvv) Model Number DYNJ52774, UDI/DI (EA) 10889942322473, UDI/DI (CS) 40889942322474; wwww) Model Number DYNJ52806C, UDI/DI (EA) 10193489292909, UDI/DI (CS) 40193489292900; xxxx) Model Number DYNJ53095, UDI/DI (EA) 10889942371778, UDI/DI (CS) 40889942371779; yyyy) Model Number DYNJ53481D, UDI/DI (EA) 10193489812572, UDI/DI (CS) 40193489812573; zzzz) Model Number DYNJ54755I, UDI/DI (EA) 10195327021269, UDI/DI (CS) 40195327021260

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 8 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Model Number DYNJ56547C; f) HYBRID, Model Number DYNJ57049G; g) HYBRID, Model Number DYNJ57049I; h) HYBRID, Model Number DYNJ57049J; i) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C; j) GENERAL ANGIO PACK, Model Number DYNJ57760C; k) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C; l) ANGIO PACK, Model Number DYNJ58111D; m) ANGIO PACK, Model Number DYNJ58111F; n) PORT PACK, Model Number DYNJ58162; o) ENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B; p) PERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A; q) OR ANGIO PACK, Model Number DYNJ59184B; r) PORT A CATH PACK, Model Number DYNJ59307F; s) CATH PACK, Model Number DYNJ59632D; t) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112B; u) I.R. PACK, Model Number DYNJ60343B; v) I.R. PACK, Model Number DYNJ60343C; w) CATH LAB PACK, Model Number DYNJ60763; x) CRMC ANGIOGRAM-LF, Model Number DYNJ61082C; y) CRMC ANGIOGRAM-LF, Model Number DYNJ61082D; z) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B; aa) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C; bb) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C; cc) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D; dd) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F; ee) MAIN OR CATH LAB, Model Number DYNJ61373A; ff) CARDIAC CATH PACK-LF, Model Number DYNJ61527A; gg) IR PACK, Model Number DYNJ61646A; hh) PERMA CATH PACK, Model Number DYNJ62007A; ii) IR PACK, Model Number DYNJ62037D; jj) AV FISTULA PACK, Model Number DYNJ62733A; kk) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B; ll) CATH PACK, Model Number DYNJ63181A; mm) CATH PACK, Model Number DYNJ63181B; nn) CATH PACK, Model Number DYNJ63181C; oo) CATH ANGIO PACK, Model Number DYNJ64050A; pp) ANGIOPLASTY PACK-LF, Model Number DYNJ64655C; qq) IR GENERAL PACK, Model Number DYNJ64976; rr) HEART TAVR PACK, Model Number DYNJ65174D; ss) ANGIOGRAPHY PACK, Model Number DYNJ65190D; tt) ANGIOGRAPHY PACK, Model Number DYNJ65190F; uu) PACK,CARDIAC CATH, Model Number DYNJ65481; vv) RADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913; ww) CATH LAB PACK, Model Number DYNJ66166A; xx) CATH I W SPLIT DRAPE PACK, Model Number DYNJ66182; yy) PORT A CATH INSERT PK, Model Number DYNJ66257; zz) PORT A CATH INSERT PK, Model Number DYNJ66257A; aaa) PORT A CATH INSERT PK, Model Number DYNJ66257B; bbb) FISTULAGRAM PACK, Model Number DYNJ66259A; ccc) ANGIOGRAM SET UP PACK, Model Number DYNJ66260A; ddd) CATH PACK, Model Number DYNJ66473A; eee) ANGIOGRAPHY PACK, Model Number DYNJ66476A; fff) FEMORAL PACK, Model Number DYNJ66515A; ggg) IR PACK UNION, Model Number DYNJ66926A; hhh) STANDARD ANGIO TRAY MV, Model Number DYNJ67136A; iii) ANGIOGRAPHY PACK, Model Number DYNJ67144A; jjj) DRAINAGE PROCEDURE PACK, Model Number DYNJ67149A; kkk) CARDIAC CATH PACK, Model Number DYNJ67174A; lll) CARDIAC CATH PACK, Model Number DYNJ67174B; mmm) OR ANGIOGRAPHY PACK, Model Number DYNJ67245A; nnn) OR ANGIOGRAPHY PACK, Model Number DYNJ67245B; ooo) ANGIOGRAPHIC TRAY, Model Number DYNJ67320A; ppp) IR PACK, Model Number DYNJ67737; qqq) TUNNEL LINE PACK, Model Number DYNJ67990A; rrr) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B; sss) NEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B; ttt) IR PACK, Model Number DYNJ68538; uuu) SPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729; vvv) IR PACK, Model Number DYNJ68729B; www) CATH LAB ANGIO TRAY, Model Number DYNJ68763; xxx) CATH LAB ANGIO TRAY, Model Number DYNJ68763A; yyy) IR RADIOLOGY PACK, Model Number DYNJ69056; zzz) IR RADIOLOGY PACK, Model Number DYNJ69056A; aaaa) ANGIO PACK, Model Number DYNJ69200; bbbb) HGH TAVI PACK, Model Number DYNJ69298; cccc) ANGIO TRAY, Model Number DYNJ69421; dddd) ENDOV

Z-2161-2023
Recall number
Z-2161-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
3,740,814 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ55252C, UDI/DI (EA)10195327267919, UDI/DI (CS)40195327267910; b) Model Number DYNJ55455A, UDI/DI (EA)10193489386233, UDI/DI (CS)40193489386234; c) Model Number DYNJ55680A, UDI/DI (EA)10889942639786, UDI/DI (CS)40889942639787; d) Model Number DYNJ56038A, UDI/DI (EA)10195327347840, UDI/DI (CS)40195327347841; e) Model Number DYNJ56547C, UDI/DI (EA)10193489879834, UDI/DI (CS)40193489879835; f) Model Number DYNJ57049G, UDI/DI (EA)10195327110390, UDI/DI (CS)40195327110391; g) Model Number DYNJ57049I, UDI/DI (EA)10195327207731, UDI/DI (CS)40195327207732; h) Model Number DYNJ57049J, UDI/DI (EA)10195327290658, UDI/DI (CS)40195327290659; i) Model Number DYNJ57645C, UDI/DI (EA)10195327287412, UDI/DI (CS)40195327287413; j) Model Number DYNJ57760C, UDI/DI (EA)10195327079390, UDI/DI (CS)40195327079391; k) Model Number DYNJ57792C, UDI/DI (EA)10195327209902, UDI/DI (CS)40195327209903; l) Model Number DYNJ58111D, UDI/DI (EA)10193489932928, UDI/DI (CS)40193489932929; m) Model Number DYNJ58111F, UDI/DI (EA)10195327223519, UDI/DI (CS)40195327223510; n) Model Number DYNJ58162, UDI/DI (EA)10889942829330, UDI/DI (CS)40889942829331; o) Model Number DYNJ58178B, UDI/DI (EA)10195327209919, UDI/DI (CS)40195327209910; p) Model Number DYNJ58510A, UDI/DI (EA)10193489817430, UDI/DI (CS)40193489817431; q) Model Number DYNJ59184B, UDI/DI (EA)10193489949100, UDI/DI (CS)40193489949101; r) Model Number DYNJ59307F, UDI/DI (EA)10195327058852, UDI/DI (CS)40195327058853; s) Model Number DYNJ59632D, UDI/DI (EA)10195327034078, UDI/DI (CS)40195327034079; t) Model Number DYNJ60112B, UDI/DI (EA)10195327118846, UDI/DI (CS)40195327118847; u) Model Number DYNJ60343B, UDI/DI (EA)10195327215491, UDI/DI (CS)40195327215492; v) Model Number DYNJ60343C, UDI/DI (EA)10195327285043, UDI/DI (CS)40195327285044; w) Model Number DYNJ60763, UDI/DI (EA)10193489527964, UDI/DI (CS)40193489527965; x) Model Number DYNJ61082C, UDI/DI (EA)10195327111410, UDI/DI (CS)40195327111411; y) Model Number DYNJ61082D, UDI/DI (EA)10195327261993, UDI/DI (CS)40195327261994; z) Model Number DYNJ61099B, UDI/DI (EA)10195327111854, UDI/DI (CS)40195327111855; aa) Model Number DYNJ61099C, UDI/DI (EA)10195327262006, UDI/DI (CS)40195327262007; bb) Model Number DYNJ61118C, UDI/DI (EA)10193489463972, UDI/DI (CS)40193489463973; cc) Model Number DYNJ61118D, UDI/DI (EA)10195327108212, UDI/DI (CS)40195327108213; dd) Model Number DYNJ61118F, UDI/DI (EA)10195327261986, UDI/DI (CS)40195327261987; ee) Model Number DYNJ61373A, UDI/DI (EA)10195327014698, UDI/DI (CS)40195327014699; ff) Model Number DYNJ61527A, UDI/DI (EA)10195327383800, UDI/DI (CS)40195327383801; gg) Model Number DYNJ61646A, UDI/DI (EA)10195327014315, UDI/DI (CS)40195327014316; hh) Model Number DYNJ62007A, UDI/DI (EA)10193489878905, UDI/DI (CS)40193489878906; ii) Model Number DYNJ62037D, UDI/DI (EA)10193489893694, UDI/DI (CS)40193489893695; jj) Model Number DYNJ62733A, UDI/DI (EA)10193489970678, UDI/DI (CS)40193489970679; kk) Model Number DYNJ63060B, UDI/DI (EA)10193489912821, UDI/DI (CS)40193489912822; ll) Model Number DYNJ63181A, UDI/DI (EA)10195327045487, UDI/DI (CS)40195327045488; mm) Model Number DYNJ63181B, UDI/DI (EA)10195327127213, UDI/DI (CS)40195327127214; nn) Model Number DYNJ63181C, UDI/DI (EA)10195327242008, UDI/DI (CS)40195327242009; oo) Model Number DYNJ64050A, UDI/DI (EA)10193489943825, UDI/DI (CS)40193489943826; pp) Model Number DYNJ64655C, UDI/DI (EA)10195327172893, UDI/DI (CS)40195327172894; qq) Model Number DYNJ64976, UDI/DI (EA)10193489237122, UDI/DI (CS)40193489237123; rr) Model Number DYNJ65174D, UDI/DI (EA)10193489962154, UDI/DI (CS)40193489962155; ss) Model Number DYNJ65190D, UDI/DI (EA)10195327066642, UDI/DI (CS)40195327066643; tt) Model Number DYNJ65190F, UDI/DI (EA)10195327092658, UDI/DI (CS)40195327092659; uu) Model Number DYNJ65481, UDI/DI (EA)10193489280463, UDI/DI (CS)40193489280464; vv) Model Number DYNJ65913, UDI/DI (EA)10193489303179, UDI/DI (CS)40193489303170; ww) Model Number DYNJ66166A, UDI/DI (EA)10193489395990, UDI/DI (CS)40193489395991; xx) Model Number DYNJ66182, UDI/DI (EA)10193489320985, UDI/DI (CS)40193489320986; yy) Model Number DYNJ66257, UDI/DI (EA)10193489325492, UDI/DI (CS)40193489325493; zz) Model Number DYNJ66257A, UDI/DI (EA)10193489947502, UDI/DI (CS)40193489947503; aaa) Model Number DYNJ66257B, UDI/DI (EA)10195327185831, UDI/DI (CS)40195327185832; bbb) Model Number DYNJ66259A, UDI/DI (EA)10195327185732, UDI/DI (CS)40195327185733; ccc) Model Number DYNJ66260A, UDI/DI (EA)10195327185749, UDI/DI (CS)40195327185740; ddd) Model Number DYNJ66473A, UDI/DI (EA)10193489917772, UDI/DI (CS)40193489917773; eee) Model Number DYNJ66476A, UDI/DI (EA)10195327051891, UDI/DI (CS)40195327051892; fff) Model Number DYNJ66515A, UDI/DI (EA)10193489406160, UDI/DI (CS)40193489406161; ggg) Model Number DYNJ66926A, UDI/DI (EA)10193489887358, UDI/DI (CS)40193489887359; hhh) Model Number DYNJ67136A, UDI/DI (EA)10193489935677, UDI/DI (CS)40193489935678; iii) Model Number DYNJ67144A, UDI/DI (EA)10195327179021, UDI/DI (CS)40195327179022; jjj) Model Number DYNJ67149A, UDI/DI (EA)10195327179038, UDI/DI (CS)40195327179039; kkk) Model Number DYNJ67174A, UDI/DI (EA)10195327046804, UDI/DI (CS)40195327046805; lll) Model Number DYNJ67174B, UDI/DI (EA)10195327131081, UDI/DI (CS)40195327131082; mmm) Model Number DYNJ67245A, UDI/DI (EA)10195327024253, UDI/DI (CS)40195327024254; nnn) Model Number DYNJ67245B, UDI/DI (EA)10195327292225, UDI/DI (CS)40195327292226; ooo) Model Number DYNJ67320A, UDI/DI (EA)10193489937572, UDI/DI (CS)40193489937573; ppp) Model Number DYNJ67737, UDI/DI (EA)10193489427752, UDI/DI (CS)40193489427753; qqq) Model Number DYNJ67990A, UDI/DI (EA)10195327265335, UDI/DI (CS)40195327265336; rrr) Model Number DYNJ68065B, UDI/DI (EA)10195327013332, UDI/DI (CS)40195327013333; sss) Model Number DYNJ68365B, UDI/DI (EA)10195327161934, UDI/DI (CS)40195327161935; ttt) Model Number DYNJ68538, UDI/DI (EA)10193489833119, UDI/DI (CS)40193489833110; uuu) Model Number DYNJ68729, UDI/DI (EA)10193489836547, UDI/DI (CS)40193489836548; vvv) Model Number DYNJ68729B, UDI/DI (EA)10195327020910, UDI/DI (CS)40195327020911; www) Model Number DYNJ68763, UDI/DI (EA)10193489837599, UDI/DI (CS)40193489837590; xxx) Model Number DYNJ68763A, UDI/DI (EA)10195327264789, UDI/DI (CS)40195327264780; yyy) Model Number DYNJ69056, UDI/DI (EA)10193489886870, UDI/DI (CS)40193489886871; zzz) Model Number DYNJ69056A, UDI/DI (EA)10195327061296, UDI/DI (CS)40195327061297; aaaa) Model Number DYNJ69200, UDI/DI (EA)10193489906813, UDI/DI (CS)40193489906814; bbbb) Model Number DYNJ69298, UDI/DI (EA)10193489925418, UDI/DI (CS)40193489925419; cccc) Model Number DYNJ69421, UDI/DI (EA)10193489937596, UDI/DI (CS)40193489937597; dddd) Model Number DYNJ69691, UDI/DI (EA)10193489970111, UDI/DI (CS)40193489970112; eeee) Model Number DYNJ69742B, UDI/DI (EA)10195327136888, UDI/DI (CS)40195327136889; ffff) Model Number DYNJ69763A, UDI/DI (EA)10195327330019, UDI/DI (CS)40195327330010; gggg) Model Number DYNJ69864, UDI/DI (EA)10193489990485, UDI/DI (CS)40193489990486; hhhh) Model Number DYNJ69944, UDI/DI (EA)10193489998450, UDI/DI (CS)40193489998451; iiii) Model Number DYNJ69944A, UDI/DI (EA)10195327285364, UDI/DI (CS)40195327285365; jjjj) Model Number DYNJ69951, UDI/DI (EA)10195327000301, UDI/DI (CS)40195327000302; kkkk) Model Number DYNJ80269, UDI/DI (EA)10195327017804, UDI/DI (CS)40195327017805; llll) Model Number DYNJ80297, UDI/DI (EA)10195327021771, UDI/DI (CS)40195327021772; mmmm) Model Number DYNJ80297A, UDI/DI (EA)10195327372170, UDI/DI (CS)40195327372171; nnnn) Model Number DYNJ81213, UDI/DI (EA)10195327094270, UDI/DI (CS)40195327094271; oooo) Model Number DYNJ81213A, UDI/DI (EA)10195327319250, UDI/DI (CS)40195327319251; pppp) Model Number DYNJ81316, UDI/DI (EA)10195327103798, UDI/DI (CS)40195327103799; qqqq) Model Number DYNJ81429A, UDI/DI (EA)10195327321642, UDI/DI (CS)40195327321643; rrrr) Model Number DYNJ81435B, UDI/DI (EA)10195327324834, UDI/DI (CS)40195327324835; ssss) Model Number DYNJ82030, UDI/DI (EA)10195327162375, UDI/DI (CS)40195327162376; tttt) Model Number DYNJ82041, UDI/DI (EA)10195327162214, UDI/DI (CS)40195327162215; uuuu) Model Number DYNJ82079, UDI/DI (EA)10195327167363, UDI/DI (CS)40195327167364; vvvv) Model Number DYNJ82280, UDI/DI (EA)10195327183929, UDI/DI (CS)40195327183920; wwww) Model Number DYNJ82296, UDI/DI (EA)10195327184209, UDI/DI (CS)40195327184200; xxxx) Model Number DYNJ82999, UDI/DI (EA)10195327223106, UDI/DI (CS)40195327223107; yyyy) Model Number DYNJ82999A, UDI/DI (EA)10195327310271, UDI/DI (CS)40195327310272; zzzz) Model Number DYNJ83089, UDI/DI (EA)10195327230838, UDI/DI (CS)40195327230839;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 9 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C

Z-2162-2023
Recall number
Z-2162-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ83105, UDI/DI (EA)10195327231514, UDI/DI (CS)40195327231515; b) Model Number DYNJ83251, UDI/DI (EA)10195327248659, UDI/DI (CS)40195327248650; c) Model Number DYNJ83508, UDI/DI (EA)10195327273163, UDI/DI (CS)40195327273164; d) Model Number DYNJ83656, UDI/DI (EA)10195327288228, UDI/DI (CS)40195327288229; e) Model Number DYNJ83696, UDI/DI (EA)10195327299125, UDI/DI (CS)40195327299126; f) Model Number DYNJ83746, UDI/DI (EA)10195327300692, UDI/DI (CS)40195327300693; g) Model Number DYNJ83815, UDI/DI (EA)10195327311018, UDI/DI (CS)40195327311019; h) Model Number DYNJ83918, UDI/DI (EA)10195327313807, UDI/DI (CS)40195327313808; i) Model Number DYNJ83936, UDI/DI (EA)10195327318550, UDI/DI (CS)40195327318551; j) Model Number DYNJ84040, UDI/DI (EA)10195327329709, UDI/DI (CS)40195327329700; k) Model Number DYNJ84190, UDI/DI (EA)10195327341961, UDI/DI (CS)40195327341962; l) Model Number DYNJ902507C, UDI/DI (EA)10195327137885, UDI/DI (CS)40195327137886; m) Model Number DYNJ902507D, UDI/DI (EA)10195327336561, UDI/DI (CS)40195327336562; n) Model Number DYNJ905151B, UDI/DI (EA)10195327219963, UDI/DI (CS)40195327219964; o) Model Number DYNJ906766B, UDI/DI (EA)10195327250195, UDI/DI (CS)40195327250196; p) Model Number DYNJ908249A, UDI/DI (EA)10195327240509, UDI/DI (CS)40195327240500; q) Model Number DYNJ909267, UDI/DI (EA)10195327314613, UDI/DI (CS)40195327314614; r) Model Number DYNJVB1000, UDI/DI (EA)10193489800999, UDI/DI (CS)40193489800990; s) Model Number SYNJ10303C, UDI/DI (EA)10195327118891, UDI/DI (CS)40195327118892

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 10 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983849D; i. OPEN HEART ANESTHESIA PACK, Model Number CDS983849F; j. VNUS, Model Number CDS984292I; k. OPEN HEART CDS, Model Number CDS984355G; l. BEDSIDE PICC CDS, Model Number CDS984642; m. VASCULAR, Model Number CDS984764G; n. OPEN HEART A, Model Number CDS985105O; o. VASCULAR, Model Number CDS985355D; p. VASCULAR, Model Number CDS985355F; q. ECMO KIT, Model Number CVI4955; r. KIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21; s. VASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526; t. ARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038; u. DIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B; v. OPEN HEART CABG PACK-LF, Model Number DYNJ0149567C; w. VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ; x. OPEN HEART PACK-LF, Model Number DYNJ0371669N; y. CABG PACK, Model Number DYNJ0408782AA; z. CARDIAC EP PACK-LF, Model Number DYNJ0429185K; aa. CARDIAC EP PACK-LF, Model Number DYNJ0429185M; bb. OPEN HEART A & B PACK, Model Number DYNJ0450131AI; cc. VASCULAR PACK-LF, Model Number DYNJ0493141J; dd. RIGHT HEART PACK-LF, Model Number DYNJ0565558U; ee. ENDO VASCULAR PACK-LF, Model Number DYNJ0676055N; ff. LOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G; gg. ENDOVASCULAR PACK, Model Number DYNJ0678934I; hh. RR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J; ii. ELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D; jj. VASCULAR PACK-LF, Model Number DYNJ0871182AC; kk. ELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D; ll. EP PACK, Model Number DYNJ16618J; mm. EP PACK, Model Number DYNJ16618K; nn. ST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C; oo. VEIN PACK, Model Number DYNJ21949J; pp. VASCULAR PACK, Model Number DYNJ22350L; qq. EP PACK, Model Number DYNJ23456K; rr. ANGIO-VASCULAR, Model Number DYNJ24272C; ss. EP ANGIO PACK, Model Number DYNJ25749S; tt. C.V. MINOR PACK, Model Number DYNJ28849B; uu. EP TRAY, Model Number DYNJ31928D; vv. PACER PACK, Model Number DYNJ34844C; ww. ADULT CARDIO TRAY, Model Number DYNJ35495G; xx. PEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G; yy. CARDIO B PACK, Model Number DYNJ36052O; zz. VASCULAR ENDO LASER PK, Model Number DYNJ37445I; aaa. VEIN PROCEDURE PACK, Model Number DYNJ38264D; bbb. HMT VEIN PACK, Model Number DYNJ38756B; ccc. LASER AND VEIN PACK, Model Number DYNJ38995C; ddd. VEIN CLOSURE PACK, Model Number DYNJ39408F; eee. CAROTID PACK, Model Number DYNJ39488G; fff. VEIN PACK, Model Number DYNJ39889; ggg. CVL CUSTOM PACK, Model Number DYNJ40067G; hhh. AV GRAFT-LF, Model Number DYNJ40077F; iii. VASCULAR-LF, Model Number DYNJ40108I; jjj. INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C; kkk. RIGHT HEART TRAY, Model Number DYNJ40379D; lll. LINE PACK, Model Number DYNJ41100C; mmm. CARDIAC CATH PACK, Model Number DYNJ41195D; nnn. VEIN PK, Model Number DYNJ42976; ooo. VEIN CLOSURE PACK, Model Number DYNJ43085A; ppp. PROCEDURE PACK, Model Number DYNJ43922; qqq. PK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B; rrr. PACEMAKER PACK, Model Number DYNJ44345F; sss. PACEMAKER PACK, Model Number DYNJ44345G; ttt. VENOUS ACCESS PACK, Model Number DYNJ44421D; uuu. VEIN CLOSURE TRAY, Model Number DYNJ44737B; vvv. ENDO LASER ABLATION PK-LF, Model Number DYNJ44808G; www. PK, OPEN HEART, Model Number DYNJ45074C; xxx. VASCULAR PACK, Model Number DYNJ46246A; yyy. CVP PACK, Model Number DYNJ46359D; zzz. INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B; aaaa. EP DRAPE PACK-LF, Model Number DYNJ47645C; bbbb. RF OPEN HEAR

Z-2163-2023
Recall number
Z-2163-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
172722 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number 00-401185Q, UDI/DI (EA) 10193489489088, UDI/DI (CS)40193489489089; b) Model Number CDS840487I, UDI/DI (EA) 10193489445343, UDI/DI (CS)40193489445344; c) Model Number CDS983147I, UDI/DI (EA) 10195327075514, UDI/DI (CS)40195327075515; d) Model Number CDS983394I, UDI/DI (EA) 10193489819953, UDI/DI (CS)40193489819954; e) Model Number CDS983394J, UDI/DI (EA) 10195327069872, UDI/DI (CS)40195327069873; f) Model Number CDS983394K, UDI/DI (EA) 10195327292584, UDI/DI (CS)40195327292585; g) Model Number CDS983513F, UDI/DI (EA) 10193489843729, UDI/DI (CS)40193489843720; h) Model Number CDS983849D, UDI/DI (EA) 10193489278231, UDI/DI (CS)40193489278232; i) Model Number CDS983849F, UDI/DI (EA) 10195327228316, UDI/DI (CS)40195327228317; j) Model Number CDS984292I, UDI/DI (EA) 10193489862485, UDI/DI (CS)40193489862486; k) Model Number CDS984355G, UDI/DI (EA) 10193489484632, UDI/DI (CS)40193489484633; l) Model Number CDS984642, UDI/DI (EA) 10884389882924, UDI/DI (CS)40884389882925; m) Model Number CDS984764G, UDI/DI (EA) 10193489450293, UDI/DI (CS)40193489450294; n) Model Number CDS985105O, UDI/DI (EA) 10195327036249, UDI/DI (CS)40195327036240; o) Model Number CDS985355D, UDI/DI (EA) 10193489442779, UDI/DI (CS)40193489442770; p) Model Number CDS985355F, UDI/DI (EA) 10195327242626, UDI/DI (CS)40195327242627; q) Model Number CVI4955, UDI/DI (EA) 10195327325848, UDI/DI (CS)40195327325849; r) Model Number DYKMBNDL21, UDI/DI (EA) 10193489478693, UDI/DI (CS)40193489478694; s) Model Number DYNDA2526, UDI/DI (EA) 10193489191790, UDI/DI (CS)40193489191791; t) Model Number DYNDC3038, UDI/DI (EA) 10193489493603, UDI/DI (CS)40193489493604; u) Model Number DYNJ0037939B, UDI/DI (EA) 10195327031275, UDI/DI (CS)40195327031276; v) Model Number DYNJ0149567C, UDI/DI (EA) 10195327235529, UDI/DI (CS)40195327235520; w) Model Number DYNJ0201109AJ, UDI/DI (EA) 10195327325459, UDI/DI (CS)40195327325450; x) Model Number DYNJ0371669N, UDI/DI (EA) 10193489230390, UDI/DI (CS)40193489230391; y) Model Number DYNJ0408782AA, UDI/DI (EA) 10195327115814, UDI/DI (CS)40195327115815; z) Model Number DYNJ0429185K, UDI/DI (EA) 10193489728132, UDI/DI (CS)40193489728133; aa) Model Number DYNJ0429185M, UDI/DI (EA) 10195327371357, UDI/DI (CS)40195327371358; bb) Model Number DYNJ0450131AI, UDI/DI (EA) 10193489466126, UDI/DI (CS)40193489466127; cc) Model Number DYNJ0493141J, UDI/DI (EA) 10193489926224, UDI/DI (CS)40193489926225; dd) Model Number DYNJ0565558U, UDI/DI (EA) 10193489827033, UDI/DI (CS)40193489827034; ee) Model Number DYNJ0676055N, UDI/DI (EA) 10193489954364, UDI/DI (CS)40193489954365; ff) Model Number DYNJ0678934G, UDI/DI (EA) 10193489925265, UDI/DI (CS)40193489925266; gg) Model Number DYNJ0678934I, UDI/DI (EA) 10193489997866, UDI/DI (CS)40193489997867; hh) Model Number DYNJ0785736J, UDI/DI (EA) 10193489202663, UDI/DI (CS)40193489202664; ii) Model Number DYNJ0842825D, UDI/DI (EA) 10195327288617, UDI/DI (CS)40195327288618; jj) Model Number DYNJ0871182AC, UDI/DI (EA) 10195327330859, UDI/DI (CS)40195327330850; kk) Model Number DYNJ09878D, UDI/DI (EA) 10195327387662, UDI/DI (CS)40195327387663; ll) Model Number DYNJ16618J, UDI/DI (EA) 10195327249854, UDI/DI (CS)40195327249855; mm) Model Number DYNJ16618K, UDI/DI (EA) 10195327325572, UDI/DI (CS)40195327325573; nn) Model Number DYNJ20031C, UDI/DI (EA) 10884389650073, UDI/DI (CS)40884389650074; oo) Model Number DYNJ21949J, UDI/DI (EA) 10889942128419, UDI/DI (CS)40889942128410; pp) Model Number DYNJ22350L, UDI/DI (EA) 10193489445251, UDI/DI (CS)40193489445252; qq) Model Number DYNJ23456K, UDI/DI (EA) 10193489967760, UDI/DI (CS)40193489967761; rr) Model Number DYNJ24272C, UDI/DI (EA) 10193489620221, UDI/DI (CS)40193489620222; ss) Model Number DYNJ25749S, UDI/DI (EA) 10195327059705, UDI/DI (CS)40195327059706; tt) Model Number DYNJ28849B, UDI/DI (EA) 10195327319557, UDI/DI (CS)40195327319558; uu) Model Number DYNJ31928D, UDI/DI (EA) 10195327335281, UDI/DI (CS)40195327335282; vv) Model Number DYNJ34844C, UDI/DI (EA) 10193489778076, UDI/DI (CS)40193489778077; ww) Model Number DYNJ35495G, UDI/DI (EA) 10193489803990, UDI/DI (CS)40193489803991; xx) Model Number DYNJ35578G, UDI/DI (EA) 10193489808605, UDI/DI (CS)40193489808606; yy) Model Number DYNJ36052O, UDI/DI (EA) 10195327249533, UDI/DI (CS)40195327249534; zz) Model Number DYNJ37445I, UDI/DI (EA) 10193489417395, UDI/DI (CS)40193489417396; aaa) Model Number DYNJ38264D, UDI/DI (EA) 10193489438499, UDI/DI (CS)40193489438490; bbb) Model Number DYNJ38756B, UDI/DI (EA) 10889942455799, UDI/DI (CS)40889942455790; ccc) Model Number DYNJ38995C, UDI/DI (EA) 10193489713145, UDI/DI (CS)40193489713146; ddd) Model Number DYNJ39408F, UDI/DI (EA) 10193489692839, UDI/DI (CS)40193489692830; eee) Model Number DYNJ39488G, UDI/DI (EA) 10193489383775, UDI/DI (CS)40193489383776; fff) Model Number DYNJ39889, UDI/DI (EA) 10884389796931, UDI/DI (CS)40884389796932; ggg) Model Number DYNJ40067G, UDI/DI (EA) 10195327244033, UDI/DI (CS)40195327244034; hhh) Model Number DYNJ40077F, UDI/DI (EA) 10195327175818, UDI/DI (CS)40195327175819; iii) Model Number DYNJ40108I, UDI/DI (EA) 10195327284183, UDI/DI (CS)40195327284184; jjj) Model Number DYNJ40215C, UDI/DI (EA) 10195327176501, UDI/DI (CS)40195327176502; kkk) Model Number DYNJ40379D, UDI/DI (EA) 10193489257618, UDI/DI (CS)40193489257619; lll) Model Number DYNJ41100C, UDI/DI (EA) 10193489899825, UDI/DI (CS)40193489899826; mmm) Model Number DYNJ41195D, UDI/DI (EA) 10193489314250, UDI/DI (CS)40193489314251; nnn) Model Number DYNJ42976, UDI/DI (EA) 10888277019140, UDI/DI (CS)40888277019141; ooo) Model Number DYNJ43085A, UDI/DI (EA) 10193489600346, UDI/DI (CS)40193489600347; ppp) Model Number DYNJ43922, UDI/DI (EA) 10888277074668, UDI/DI (CS)40888277074669; qqq) Model Number DYNJ44087B, UDI/DI (EA) 10195327346584, UDI/DI (CS)40195327346585; rrr) Model Number DYNJ44345F, UDI/DI (EA) 10889942966523, UDI/DI (CS)40889942966524; sss) Model Number DYNJ44345G, UDI/DI (EA) 10193489939507, UDI/DI (CS)40193489939508; ttt) Model Number DYNJ44421D, UDI/DI (EA) 10193489482638, UDI/DI (CS)40193489482639; uuu) Model Number DYNJ44737B, UDI/DI (EA) 10193489351712, UDI/DI (CS)40193489351713; vvv) Model Number DYNJ44808G, UDI/DI (EA) 10193489875850, UDI/DI (CS)40193489875851; www) Model Number DYNJ45074C, UDI/DI (EA) 10193489222678, UDI/DI (CS)40193489222679; xxx) Model Number DYNJ46246A, UDI/DI (EA) 10889942584963, UDI/DI (CS)40889942584964; yyy) Model Number DYNJ46359D, UDI/DI (EA) 10193489961379, UDI/DI (CS)40193489961370; zzz) Model Number DYNJ47138B, UDI/DI (EA) 10889942274215, UDI/DI (CS)40889942274216; aaaa) Model Number DYNJ47645C, UDI/DI (EA) 10195327355173, UDI/DI (CS)40195327355174; bbbb) Model Number DYNJ47660K, UDI/DI (EA) 10193489875737, UDI/DI (CS)40193489875738; cccc) Model Number DYNJ48365, UDI/DI (EA) 10888277594593, UDI/DI (CS)40888277594594; dddd) Model Number DYNJ48456C, UDI/DI (EA) 10195327015862, UDI/DI (CS)40195327015863; eeee) Model Number DYNJ48907F, UDI/DI (EA) 10889942529421, UDI/DI (CS)40889942529422; ffff) Model Number DYNJ49874, UDI/DI (EA) 10888277890602, UDI/DI (CS)40888277890603; gggg) Model Number DYNJ49931I, UDI/DI (EA) 10193489939217, UDI/DI (CS)40193489939218; hhhh) Model Number DYNJ49933I, UDI/DI (EA) 10193489471687, UDI/DI (CS)40193489471688; iiii) Model Number DYNJ49933J, UDI/DI (EA) 10195327065614, UDI/DI (CS)40195327065615; jjjj) Model Number DYNJ50227C, UDI/DI (EA) 10889942938612, UDI/DI (CS)40889942938613; kkkk) Model Number DYNJ50785, UDI/DI (EA) 10889942105304, UDI/DI (CS)40889942105305; llll) Model Number DYNJ51304C, UDI/DI (EA) 10193489460988, UDI/DI (CS)40193489460989; mmmm) Model Number DYNJ51925F, UDI/DI (EA) 10195327153397, UDI/DI (CS)40195327153398; nnnn) Model Number DYNJ52024, UDI/DI (EA) 10889942233359, UDI/DI (CS)40889942233350; oooo) Model Number DYNJ52056C, UDI/DI (EA) 10193489369441, UDI/DI (CS)40193489369442; pppp) Model Number DYNJ52056D, UDI/DI (EA) 10195327096137, UDI/DI (CS)40195327096138; qqqq) Model Number DYNJ52098, UDI/DI (EA) 10889942237067, UDI/DI (CS)40889942237068; rrrr) Model Number DYNJ52586A, UDI/DI (EA) 10193489494396, UDI/DI (CS)40193489494397; ssss) Model Number DYNJ52586B, UDI/DI (EA) 10195327212117, UDI/DI (CS)40195327212118; tttt) Model Number DYNJ52606F, UDI/DI (EA) 10193489343298, UDI/DI (CS)40193489343299; uuuu) Model Number DYNJ52756A, UDI/DI (EA) 10193489413830, UDI/DI (CS)40193489413831; vvvv) Model Number DYNJ52766A, UDI/DI (EA) 10193489292367, UDI/DI (CS)40193489292368; wwww) Model Number DYNJ53433F, UDI/DI (EA) 10193489328677, UDI/DI (CS)40193489328678; xxxx) Model Number DYNJ53433G, UDI/DI (EA) 10195327042431, UDI/DI (CS)40195327042432; yyyy) Model Number DYNJ53433I, UDI/DI (EA) 10195327074494, UDI/DI (CS)40195327074495; zzzz) Model Number DYNJ53433J, UDI/DI (EA) 10195327222925, UDI/DI (CS)40195327222926;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 11 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART FAILURE PK, Model Number DYNJ55528A; j) HEART FAILURE PK, Model Number DYNJ55528B; k) HEART FAILURE PK, Model Number DYNJ55528C; l) ROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C; m) OPEN HEART ANGIO PACK, Model Number DYNJ55836B; n) DR NACKMAN VEIN PACK, Model Number DYNJ56235; o) KT TAVR PACK, Model Number DYNJ56283D; p) KT TAVR PACK, Model Number DYNJ56283F; q) VEIN PACK, Model Number DYNJ56724B; r) VASCULAR PACK, Model Number DYNJ56791A; s) VASCULAR PACK, Model Number DYNJ56791B; t) ECMO PACK, Model Number DYNJ56904; u) VEIN KIT, Model Number DYNJ57047; v) EH TAVR PACK, Model Number DYNJ57449F; w) EH TAVR PACK, Model Number DYNJ57449G; x) VASCULAR PACK, Model Number DYNJ57490A; y) VEIN PACK, Model Number DYNJ57512; z) DEVICE PACK, Model Number DYNJ57595A; aa) CAROTID PACK-LF, Model Number DYNJ57646B; bb) CAROTID PACK-LF, Model Number DYNJ57646C; cc) CATH LAB PACK, Model Number DYNJ57735F; dd) VEIN PACK, Model Number DYNJ57835; ee) VEIN PACK, Model Number DYNJ57917; ff) ENS. THROMBOLYSE/EMBOLISAT-LF, Model Number DYNJ58179C; gg) HEART VALVE PACK, Model Number DYNJ58365J; hh) VEIN PACK, Model Number DYNJ58609; ii) VASCULAR PACK, Model Number DYNJ58681A; jj) VASCULAR PACK, Model Number DYNJ58681B; kk) VASCULAR PACK, Model Number DYNJ58710; ll) DR HARRISON VEIN PACK II, Model Number DYNJ59028A; mm) VEIN PACK, Model Number DYNJ59151F; nn) EP LAB, Model Number DYNJ59392D; oo) EP LAB, Model Number DYNJ59392F; pp) VEIN PACK, Model Number DYNJ59662D; qq) VEIN PACK, Model Number DYNJ59681A; rr) VASCULAR PACK CHRG, Model Number DYNJ59778B; ss) VASCULAR ACCESS KIT, Model Number DYNJ59796C; tt) CATH PACK, Model Number DYNJ59830A; uu) VENOUS ACCESS ACCESSORY PACK, Model Number DYNJ61010A; vv) DR SIRAGUSA VEIN PACK, Model Number DYNJ61247; ww) MAIN OR CATH LAB, Model Number DYNJ61373; xx) VASCULAR PACK, Model Number DYNJ61528; yy) VASCULAR PACK, Model Number DYNJ61528A; zz) VEIN PACK, Model Number DYNJ61540C; aaa) NEURO VASCULAR PACK, Model Number DYNJ61584A; bbb) ABLATION PACK, Model Number DYNJ61957A; ccc) HEART GROIN PACK, Model Number DYNJ61981C; ddd) PERMA CATH PACK, Model Number DYNJ62007B; eee) PURPLE PACK, Model Number DYNJ62197A; fff) PURPLE PACK, Model Number DYNJ62197B; ggg) CLOVIS CATH LAB PACK, Model Number DYNJ62379A; hhh) VASCULAR PACK, Model Number DYNJ62399A; iii) NORTH TEXAS VASCULAR, Model Number DYNJ62735; jjj) VEIN TRAY, Model Number DYNJ62829A; kkk) HEART VEIN NYC LASER ABLATION, Model Number DYNJ62850A; lll) HEART VEIN NYC -ARTERIAL PACK, Model Number DYNJ62851B; mmm) TAVR PACK, Model Number DYNJ62915B; nnn) PACER SET UP PACK, Model Number DYNJ63069A; ooo) OPEN HEART TAVR PACK, Model Number DYNJ63099D; ppp) OPEN HEART TAVR PACK, Model Number DYNJ63099F; qqq) ELECTROPHYSIOLOGY PACK, Model Number DYNJ63209; rrr) TAVR PACK, Model Number DYNJ63340A; sss) VEIN PACK, Model Number DYNJ63823; ttt) NIR PACK, Model Number DYNJ63892A; uuu) VEIN ABLATION TRAY W/CHLOR, Model Number DYNJ64396; vvv) TORRES-VEIN PACK, Model Number DYNJ64449; www) VEIN PACK, Model Number DYNJ64471A; xxx) CVOR ENDOVASCULAR PACK, Model Number DYNJ64506A; yyy) HEART FAILURE PACK, Model Number DYNJ64877B; zzz) CT ABLATION PACK, Model Number DYNJ64928; aaaa) VEIN PROCEDURE, Model Number DYNJ65342A; bbbb) SMALL TRAY VASCULAR PACK, Model Number DYNJ65418; cccc) VEIN OHH, Model Number DYNJ65560A; dddd) PORT PICC TUNNEL PACK, Model Number DYNJ65775A; eeee) VARITHENA PACK, Model Number DYNJ65

Z-2164-2023
Recall number
Z-2164-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ53433K, UDI/DI (EA)10195327339487, UDI/DI (CS)40195327339488; b) Model Numbers DYNJ53616A, UDI/DI (EA)10889942688562, UDI/DI (CS)40889942688563; c) Model Numbers DYNJ54014B, UDI/DI (EA)10889942760329, UDI/DI (CS)40889942760320; d) Model Numbers DYNJ54153B, UDI/DI (EA)10889942714421, UDI/DI (CS)40889942714422; e) Model Numbers DYNJ54265A, UDI/DI (EA)10195327152338, UDI/DI (CS)40195327152339; f) Model Numbers DYNJ54750G, UDI/DI (EA)10195327021351, UDI/DI (CS)40195327021352; g) Model Numbers DYNJ54803C, UDI/DI (EA)10193489202618, UDI/DI (CS)40193489202619; h) Model Numbers DYNJ54906B, UDI/DI (EA)10193489289633, UDI/DI (CS)40193489289634; i) Model Numbers DYNJ55528A, UDI/DI (EA)10889942976638, UDI/DI (CS)40889942976639; j) Model Numbers DYNJ55528B, UDI/DI (EA)10195327046491, UDI/DI (CS)40195327046492; k) Model Numbers DYNJ55528C, UDI/DI (EA)10195327248208, UDI/DI (CS)40195327248209; l) Model Numbers DYNJ55757C, UDI/DI (EA)10195327116538, UDI/DI (CS)40195327116539; m) Model Numbers DYNJ55836B, UDI/DI (EA)10193489951172, UDI/DI (CS)40193489951173; n) Model Numbers DYNJ56235, UDI/DI (EA)10889942621552, UDI/DI (CS)40889942621553; o) Model Numbers DYNJ56283D, UDI/DI (EA)10195327093877, UDI/DI (CS)40195327093878; p) Model Numbers DYNJ56283F, UDI/DI (EA)10195327211851, UDI/DI (CS)40195327211852; q) Model Numbers DYNJ56724B, UDI/DI (EA)10193489466317, UDI/DI (CS)40193489466318; r) Model Numbers DYNJ56791A, UDI/DI (EA)10193489594119, UDI/DI (CS)40193489594110; s) Model Numbers DYNJ56791B, UDI/DI (EA)10195327045678, UDI/DI (CS)40195327045679; t) Model Numbers DYNJ56904, UDI/DI (EA)10889942693450, UDI/DI (CS)40889942693451; u) Model Numbers DYNJ57047, UDI/DI (EA)10889942710485, UDI/DI (CS)40889942710486; v) Model Numbers DYNJ57449F, UDI/DI (EA)10193489939200, UDI/DI (CS)40193489939201; w) Model Numbers DYNJ57449G, UDI/DI (EA)10195327064884, UDI/DI (CS)40195327064885; x) Model Numbers DYNJ57490A, UDI/DI (EA)10193489641998, UDI/DI (CS)40193489641999; y) Model Numbers DYNJ57512, UDI/DI (EA)10889942748273, UDI/DI (CS)40889942748274; z) Model Numbers DYNJ57595A, UDI/DI (EA)10193489622157, UDI/DI (CS)40193489622158; aa) Model Numbers DYNJ57646B, UDI/DI (EA)10193489828504, UDI/DI (CS)40193489828505; bb) Model Numbers DYNJ57646C, UDI/DI (EA)10195327287139, UDI/DI (CS)40195327287130; cc) Model Numbers DYNJ57735F, UDI/DI (EA)10193489629705, UDI/DI (CS)40193489629706; dd) Model Numbers DYNJ57835, UDI/DI (EA)10889942782338, UDI/DI (CS)40889942782339; ee) Model Numbers DYNJ57917, UDI/DI (EA)10889942794294, UDI/DI (CS)40889942794295; ff) Model Numbers DYNJ58179C, UDI/DI (EA)10195327209926, UDI/DI (CS)40195327209927; gg) Model Numbers DYNJ58365J, UDI/DI (EA)10195327019099, UDI/DI (CS)40195327019090; hh) Model Numbers DYNJ58609, UDI/DI (EA)10889942871261, UDI/DI (CS)40889942871262; ii) Model Numbers DYNJ58681A, UDI/DI (EA)10888277798489, UDI/DI (CS)40888277798480; jj) Model Numbers DYNJ58681B, UDI/DI (EA)10195327293376, UDI/DI (CS)40195327293377; kk) Model Numbers DYNJ58710, UDI/DI (EA)10889942880850, UDI/DI (CS)40889942880851; ll) Model Numbers DYNJ59028A, UDI/DI (EA)10193489736595, UDI/DI (CS)40193489736596; mm) Model Numbers DYNJ59151F, UDI/DI (EA)10193489487565, UDI/DI (CS)40193489487566; nn) Model Numbers DYNJ59392D, UDI/DI (EA)10195327053574, UDI/DI (CS)40195327053575; oo) Model Numbers DYNJ59392F, UDI/DI (EA)10195327135980, UDI/DI (CS)40195327135981; pp) Model Numbers DYNJ59662D, UDI/DI (EA)10195327030872, UDI/DI (CS)40195327030873; qq) Model Numbers DYNJ59681A, UDI/DI (EA)10193489469875, UDI/DI (CS)40193489469876; rr) Model Numbers DYNJ59778B, UDI/DI (EA)10193489695922, UDI/DI (CS)40193489695923; ss) Model Numbers DYNJ59796C, UDI/DI (EA)10193489904215, UDI/DI (CS)40193489904216; tt) Model Numbers DYNJ59830A, UDI/DI (EA)10193489570236, UDI/DI (CS)40193489570237; uu) Model Numbers DYNJ61010A, UDI/DI (EA)10193489307146, UDI/DI (CS)40193489307147; vv) Model Numbers DYNJ61247, UDI/DI (EA)10193489551709, UDI/DI (CS)40193489551700; ww) Model Numbers DYNJ61373, UDI/DI (EA)10193489576696, UDI/DI (CS)40193489576697; xx) Model Numbers DYNJ61528, UDI/DI (EA)10193489578980, UDI/DI (CS)40193489578981; yy) Model Numbers DYNJ61528A, UDI/DI (EA)10195327336714, UDI/DI (CS)40195327336715; zz) Model Numbers DYNJ61540C, UDI/DI (EA)10193489495126, UDI/DI (CS)40193489495127; aaa) Model Numbers DYNJ61584A, UDI/DI (EA)10193489812817, UDI/DI (CS)40193489812818; bbb) Model Numbers DYNJ61957A, UDI/DI (EA)10193489699074, UDI/DI (CS)40193489699075; ccc) Model Numbers DYNJ61981C, UDI/DI (EA)10195327106027, UDI/DI (CS)40195327106028; ddd) Model Numbers DYNJ62007B, UDI/DI (EA)10195327161965, UDI/DI (CS)40195327161966; eee) Model Numbers DYNJ62197A, UDI/DI (EA)10193489994094, UDI/DI (CS)40193489994095; fff) Model Numbers DYNJ62197B, UDI/DI (EA)10195327167240, UDI/DI (CS)40195327167241; ggg) Model Numbers DYNJ62379A, UDI/DI (EA)10195327196639, UDI/DI (CS)40195327196630; hhh) Model Numbers DYNJ62399A, UDI/DI (EA)10193489250268, UDI/DI (CS)40193489250269; iii) Model Numbers DYNJ62735, UDI/DI (EA)10193489685282, UDI/DI (CS)40193489685283; jjj) Model Numbers DYNJ62829A, UDI/DI (EA)10193489306620, UDI/DI (CS)40193489306621; kkk) Model Numbers DYNJ62850A, UDI/DI (EA)10193489784237, UDI/DI (CS)40193489784238; lll) Model Numbers DYNJ62851B, UDI/DI (EA)10193489271218, UDI/DI (CS)40193489271219; mmm) Model Numbers DYNJ62915B, UDI/DI (EA)10193489365351, UDI/DI (CS)40193489365352; nnn) Model Numbers DYNJ63069A, UDI/DI (EA)10193489423617, UDI/DI (CS)40193489423618; ooo) Model Numbers DYNJ63099D, UDI/DI (EA)10193489932690, UDI/DI (CS)40193489932691; ppp) Model Numbers DYNJ63099F, UDI/DI (EA)10195327150037, UDI/DI (CS)40195327150038; qqq) Model Numbers DYNJ63209, UDI/DI (EA)10193489727883, UDI/DI (CS)40193489727884; rrr) Model Numbers DYNJ63340A, UDI/DI (EA)10195327273583, UDI/DI (CS)40195327273584; sss) Model Numbers DYNJ63823, UDI/DI (EA)10193489763423, UDI/DI (CS)40193489763424; ttt) Model Numbers DYNJ63892A, UDI/DI (EA)10195327176518, UDI/DI (CS)40195327176519; uuu) Model Numbers DYNJ64396, UDI/DI (EA)10193489810509, UDI/DI (CS)40193489810500; vvv) Model Numbers DYNJ64449, UDI/DI (EA)10193489201574, UDI/DI (CS)40193489201575; www) Model Numbers DYNJ64471A, UDI/DI (EA)10193489414158, UDI/DI (CS)40193489414159; xxx) Model Numbers DYNJ64506A, UDI/DI (EA)10193489971064, UDI/DI (CS)40193489971065; yyy) Model Numbers DYNJ64877B, UDI/DI (EA)10193489415896, UDI/DI (CS)40193489415897; zzz) Model Numbers DYNJ64928, UDI/DI (EA)10193489231502, UDI/DI (CS)40193489231503; aaaa) Model Numbers DYNJ65342A, UDI/DI (EA)10193489369663, UDI/DI (CS)40193489369664; bbbb) Model Numbers DYNJ65418, UDI/DI (EA)10193489273717, UDI/DI (CS)40193489273718; cccc) Model Numbers DYNJ65560A, UDI/DI (EA)10193489397185, UDI/DI (CS)40193489397186; dddd) Model Numbers DYNJ65775A, UDI/DI (EA)10195327140229, UDI/DI (CS)40195327140220; eeee) Model Numbers DYNJ65842, UDI/DI (EA)10193489296310, UDI/DI (CS)40193489296311; ffff) Model Numbers DYNJ66076, UDI/DI (EA)10193489319231, UDI/DI (CS)40193489319232; gggg) Model Numbers DYNJ66152A, UDI/DI (EA)10193489820218, UDI/DI (CS)40193489820219; hhhh) Model Numbers DYNJ66152B, UDI/DI (EA)10195327090425, UDI/DI (CS)40195327090426; iiii) Model Numbers DYNJ66271C, UDI/DI (EA)10195327098506, UDI/DI (CS)40195327098507; jjjj) Model Numbers DYNJ66356C, UDI/DI (EA)10193489991055, UDI/DI (CS)40193489991056; kkkk) Model Numbers DYNJ66356D, UDI/DI (EA)10195327060299, UDI/DI (CS)40195327060290; llll) Model Numbers DYNJ66356G, UDI/DI (EA)10195327357306, UDI/DI (CS)40195327357307; mmmm) Model Numbers DYNJ66427, UDI/DI (EA)10193489354683, UDI/DI (CS)40193489354684; nnnn) Model Numbers DYNJ66445, UDI/DI (EA)10193489356083, UDI/DI (CS)40193489356084; oooo) Model Numbers DYNJ66743A, UDI/DI (EA)10193489435559, UDI/DI (CS)40193489435550; pppp) Model Numbers DYNJ66769, UDI/DI (EA)10193489380521, UDI/DI (CS)40193489380522; qqqq) Model Numbers DYNJ66916A, UDI/DI (EA)10193489993226, UDI/DI (CS)40193489993227; rrrr) Model Numbers DYNJ66926B, UDI/DI (EA)10195327340261, UDI/DI (CS)40195327340262; ssss) Model Numbers DYNJ67487B, UDI/DI (EA)10195327166144, UDI/DI (CS)40195327166145; tttt) Model Numbers DYNJ67487C, UDI/DI (EA)10195327260743, UDI/DI (CS)40195327260744; uuuu) Model Numbers DYNJ67517A, UDI/DI (EA)10193489462197, UDI/DI (CS)40193489462198; vvvv) Model Numbers DYNJ67725, UDI/DI (EA)10193489425840, UDI/DI (CS)40193489425841; wwww) Model Numbers DYNJ67750A, UDI/DI (EA)10193489832242, UDI/DI (CS)40193489832243; xxxx) Model Numbers DYNJ67750B, UDI/DI (EA)10193489912043, UDI/DI (CS)40193489912044; yyyy) Model Numbers DYNJ67750C, UDI/DI (EA)10195327341367, UDI/DI (CS)40195327341368; zzzz) Model Numbers DYNJ67770, UDI/DI (EA)10193489430714, UDI/DI (CS)40193489430715;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 12 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TAVR PACK, Model Number DYNJ68499B; f) VEIN CLINIC, Model Number DYNJ68667; g) VASCULAR PACK, Model Number DYNJ68863; h) VASCULAR PACK, Model Number DYNJ68880; i) TAVR PACK, Model Number DYNJ68933; j) PROCEDURE PACK, Model Number DYNJ68968A; k) PORT PACK, Model Number DYNJ68990A; l) STROKE PACK, Model Number DYNJ69009A; m) ENDOVENOUS BASIC PACK, Model Number DYNJ69108A; n) VEIN ABLATION KIT, Model Number DYNJ69272A; o) UPPER ENDOVASCULAR PK, Model Number DYNJ69302; p) STROKE PACK, Model Number DYNJ69422; q) UNM PREHOSPITAL ECMO PACK, Model Number DYNJ69622; r) UNM ACCESS PACK, Model Number DYNJ69624; s) FLUSHING VASCULAR CENTER, Model Number DYNJ69626; t) AFIB PACK, Model Number DYNJ69682; u) ENDOVASCULAR PACK, Model Number DYNJ69691A; v) FISTULA SAVANNAH PACK, Model Number DYNJ69943A; w) VEIN PACK, Model Number DYNJ80199A; x) VEIN PACK, Model Number DYNJ80199B; y) VASCULAR PACK, Model Number DYNJ80310; z) CAROTID PACK, Model Number DYNJ80346A; aa) ENDOVENOUS ABLATION PACK, Model Number DYNJ80489; bb) STROKE KIT, Model Number DYNJ80506; cc) VEIN PACK, Model Number DYNJ80868; dd) VASCULAR ACCESS PACK, Model Number DYNJ81022; ee) VASCULAR GENERAL PACK, Model Number DYNJ81023; ff) AV FISTULA PACK, Model Number DYNJ81033; gg) TAVR PACK, Model Number DYNJ81095; hh) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200; ii) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200A; jj) LINQ PACK, Model Number DYNJ81320; kk) EP DRAPE, Model Number DYNJ81462A; ll) OR VASCULAR ANGIO PACK, Model Number DYNJ81592A; mm) OR VASCULAR ANGIO PACK, Model Number DYNJ81592B; nn) AV FISTULA PACK, Model Number DYNJ81605; oo) MAJOR VASCULAR PACK, Model Number DYNJ81610; pp) MAJOR VASCULAR PACK, Model Number DYNJ81610A; qq) MAJOR VASCULAR PACK, Model Number DYNJ81610B; rr) PROCEDURE PACK, Model Number DYNJ81618; ss) VASCULAR PACK, Model Number DYNJ81626; tt) VASCULAR PACK, Model Number DYNJ81626A; uu) VASCULAR KIT, Model Number DYNJ81642; vv) VASCULAR KIT, Model Number DYNJ81642A; ww) USGS PACK, Model Number DYNJ81705; xx) EP PACK, Model Number DYNJ81716; yy) EP PACK, Model Number DYNJ81716A; zz) EP PACK, Model Number DYNJ81716B; aaa) VASCULAR PACK, Model Number DYNJ82104; bbb) VASCULAR AND INTERVENTION, Model Number DYNJ82109; ccc) VASCULAR PACK, Model Number DYNJ82144; ddd) SPECIALS MINOR RADIOLOGY PACK, Model Number DYNJ82314; eee) TAVR PACK, Model Number DYNJ82372; fff) FISTULA PACK, Model Number DYNJ82711; ggg) IR ANGIOGRAM LIGHT PK, Model Number DYNJ82858A; hhh) IR ANGIOGRAM PACK, Model Number DYNJ82859A; iii) MARGIN SIMPLE VEIN PACK, Model Number DYNJ82987; jjj) MARGIN FULL VEIN PACK, Model Number DYNJ82988; kkk) MARGIN FULL VEIN PACK, Model Number DYNJ82988A; lll) ARTERIOGRAM PACK 2, Model Number DYNJ83051; mmm) VASCULAR PACK, Model Number DYNJ83146; nnn) VEIN PACK, Model Number DYNJ83147; ooo) ENDOVASCULAR PACK, Model Number DYNJ83161; ppp) CVOR ANGIOGRAPHY PACK, Model Number DYNJ83432; qqq) VIRC STROKE PACK, Model Number DYNJ83461; rrr) RADIO VEIN ABLATION PACK, Model Number DYNJ83490; sss) ENDOVENOUS PACK, Model Number DYNJ83606; ttt) ENDO VASCULAR PACK, Model Number DYNJ83624; uuu) ENDOVASCULAR PACK, Model Number DYNJ83972; vvv) TEMP PERM KIT, Model Number DYNJ84130; www) VASCULAR PACK, Model Number DYNJ84252; xxx) OPEN HEART PART 2, Model Number DYNJ901075O; yyy) OPEN HEART PART 2, Model Number DYNJ901075P; zzz) CAROTID-LF, Model Number DYNJ901745K; aaaa) VASCULAR ANGIO, Model Number DYNJ902259B; bbbb) VASCULAR CUT DOWN, Model Number DYNJ902261G; cccc) VASCULAR, Model Number DYNJ902704P; dddd) ENDOVASCULAR, Model Number DYNJ903451D; eeee) TICKER FIXER2, Model Number DYNJ903919J; ffff) TICK

Z-2165-2023
Recall number
Z-2165-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ67770A, UDI/DI (EA)10195327290979, UDI/DI (CS)40195327290970; b) Model Numbers DYNJ67771, UDI/DI (EA)10193489430721, UDI/DI (CS)40193489430722; c) Model Numbers DYNJ68019, UDI/DI (EA)10193489467840, UDI/DI (CS)40193489467841; d) Model Numbers DYNJ68198, UDI/DI (EA)10193489499179, UDI/DI (CS)40193489499170; e) Model Numbers DYNJ68499B, UDI/DI (EA)10195327034054, UDI/DI (CS)40195327034055; f) Model Numbers DYNJ68667, UDI/DI (EA)10193489837315, UDI/DI (CS)40193489837316; g) Model Numbers DYNJ68863, UDI/DI (EA)10193489845402, UDI/DI (CS)40193489845403; h) Model Numbers DYNJ68880, UDI/DI (EA)10193489847727, UDI/DI (CS)40193489847728; i) Model Numbers DYNJ68933, UDI/DI (EA)10193489860375, UDI/DI (CS)40193489860376; j) Model Numbers DYNJ68968A, UDI/DI (EA)10195327206840, UDI/DI (CS)40195327206841; k) Model Numbers DYNJ68990A, UDI/DI (EA)10193489981360, UDI/DI (CS)40193489981361; l) Model Numbers DYNJ69009A, UDI/DI (EA)10195327075569, UDI/DI (CS)40195327075560; m) Model Numbers DYNJ69108A, UDI/DI (EA)10195327025717, UDI/DI (CS)40195327025718; n) Model Numbers DYNJ69272A, UDI/DI (EA)10195327015800, UDI/DI (CS)40195327015801; o) Model Numbers DYNJ69302, UDI/DI (EA)10193489926279, UDI/DI (CS)40193489926270; p) Model Numbers DYNJ69422, UDI/DI (EA)10193489937541, UDI/DI (CS)40193489937542; q) Model Numbers DYNJ69622, UDI/DI (EA)10193489959581, UDI/DI (CS)40193489959582; r) Model Numbers DYNJ69624, UDI/DI (EA)10193489959567, UDI/DI (CS)40193489959568; s) Model Numbers DYNJ69626, UDI/DI (EA)10193489960693, UDI/DI (CS)40193489960694; t) Model Numbers DYNJ69682, UDI/DI (EA)10193489968927, UDI/DI (CS)40193489968928; u) Model Numbers DYNJ69691A, UDI/DI (EA)10195327070267, UDI/DI (CS)40195327070268; v) Model Numbers DYNJ69943A, UDI/DI (EA)10195327284633, UDI/DI (CS)40195327284634; w) Model Numbers DYNJ80199A, UDI/DI (EA)10195327040864, UDI/DI (CS)40195327040865; x) Model Numbers DYNJ80199B, UDI/DI (EA)10195327088200, UDI/DI (CS)40195327088201; y) Model Numbers DYNJ80310, UDI/DI (EA)10195327023201, UDI/DI (CS)40195327023202; z) Model Numbers DYNJ80346A, UDI/DI (EA)10195327166250, UDI/DI (CS)40195327166251; aa) Model Numbers DYNJ80489, UDI/DI (EA)10195327045845, UDI/DI (CS)40195327045846; bb) Model Numbers DYNJ80506, UDI/DI (EA)10195327049171, UDI/DI (CS)40195327049172; cc) Model Numbers DYNJ80868, UDI/DI (EA)10195327082505, UDI/DI (CS)40195327082506; dd) Model Numbers DYNJ81022, UDI/DI (EA)10195327082789, UDI/DI (CS)40195327082780; ee) Model Numbers DYNJ81023, UDI/DI (EA)10195327082796, UDI/DI (CS)40195327082797; ff) Model Numbers DYNJ81033, UDI/DI (EA)10195327082987, UDI/DI (CS)40195327082988; gg) Model Numbers DYNJ81095, UDI/DI (EA)10195327084127, UDI/DI (CS)40195327084128; hh) Model Numbers DYNJ81200, UDI/DI (EA)10195327091699, UDI/DI (CS)40195327091690; ii) Model Numbers DYNJ81200A, UDI/DI (EA)10195327224714, UDI/DI (CS)40195327224715; jj) Model Numbers DYNJ81320, UDI/DI (EA)10195327110147, UDI/DI (CS)40195327110148; kk) Model Numbers DYNJ81462A, UDI/DI (EA)10195327378615, UDI/DI (CS)40195327378616; ll) Model Numbers DYNJ81592A, UDI/DI (EA)10195327315054, UDI/DI (CS)40195327315055; mm) Model Numbers DYNJ81592B, UDI/DI (EA)10195327398309, UDI/DI (CS)40195327398300; nn) Model Numbers DYNJ81605, UDI/DI (EA)10195327123888, UDI/DI (CS)40195327123889; oo) Model Numbers DYNJ81610, UDI/DI (EA)10195327123949, UDI/DI (CS)40195327123940; pp) Model Numbers DYNJ81610A, UDI/DI (EA)10195327315047, UDI/DI (CS)40195327315048; qq) Model Numbers DYNJ81610B, UDI/DI (EA)10195327398316, UDI/DI (CS)40195327398317; rr) Model Numbers DYNJ81618, UDI/DI (EA)10195327124601, UDI/DI (CS)40195327124602; ss) Model Numbers DYNJ81626, UDI/DI (EA)10195327127060, UDI/DI (CS)40195327127061; tt) Model Numbers DYNJ81626A, UDI/DI (EA)10195327297190, UDI/DI (CS)40195327297191; uu) Model Numbers DYNJ81642, UDI/DI (EA)10195327129668, UDI/DI (CS)40195327129669; vv) Model Numbers DYNJ81642A, UDI/DI (EA)10195327266387, UDI/DI (CS)40195327266388; ww) Model Numbers DYNJ81705, UDI/DI (EA)10195327135577, UDI/DI (CS)40195327135578; xx) Model Numbers DYNJ81716, UDI/DI (EA)10195327138066, UDI/DI (CS)40195327138067; yy) Model Numbers DYNJ81716A, UDI/DI (EA)10195327203856, UDI/DI (CS)40195327203857; zz) Model Numbers DYNJ81716B, UDI/DI (EA)10195327277260, UDI/DI (CS)40195327277261; aaa) Model Numbers DYNJ82104, UDI/DI (EA)10195327171087, UDI/DI (CS)40195327171088; bbb) Model Numbers DYNJ82109, UDI/DI (EA)10195327171247, UDI/DI (CS)40195327171248; ccc) Model Numbers DYNJ82144, UDI/DI (EA)10195327178031, UDI/DI (CS)40195327178032; ddd) Model Numbers DYNJ82314, UDI/DI (EA)10195327184216, UDI/DI (CS)40195327184217; eee) Model Numbers DYNJ82372, UDI/DI (EA)10195327187538, UDI/DI (CS)40195327187539; fff) Model Numbers DYNJ82711, UDI/DI (EA)10195327203627, UDI/DI (CS)40195327203628; ggg) Model Numbers DYNJ82858A, UDI/DI (EA)10195327244897, UDI/DI (CS)40195327244898; hhh) Model Numbers DYNJ82859A, UDI/DI (EA)10195327244903, UDI/DI (CS)40195327244904; iii) Model Numbers DYNJ82987, UDI/DI (EA)10195327222116, UDI/DI (CS)40195327222117; jjj) Model Numbers DYNJ82988, UDI/DI (EA)10195327222208, UDI/DI (CS)40195327222209; kkk) Model Numbers DYNJ82988A, UDI/DI (EA)10195327293314, UDI/DI (CS)40195327293315; lll) Model Numbers DYNJ83051, UDI/DI (EA)10195327245283, UDI/DI (CS)40195327245284; mmm) Model Numbers DYNJ83146, UDI/DI (EA)10195327235680, UDI/DI (CS)40195327235681; nnn) Model Numbers DYNJ83147, UDI/DI (EA)10195327235505, UDI/DI (CS)40195327235506; ooo) Model Numbers DYNJ83161, UDI/DI (EA)10195327237837, UDI/DI (CS)40195327237838; ppp) Model Numbers DYNJ83432, UDI/DI (EA)10195327266530, UDI/DI (CS)40195327266531; qqq) Model Numbers DYNJ83461, UDI/DI (EA)10195327267797, UDI/DI (CS)40195327267798; rrr) Model Numbers DYNJ83490, UDI/DI (EA)10195327271411, UDI/DI (CS)40195327271412; sss) Model Numbers DYNJ83606, UDI/DI (EA)10195327284855, UDI/DI (CS)40195327284856; ttt) Model Numbers DYNJ83624, UDI/DI (EA)10195327285869, UDI/DI (CS)40195327285860; uuu) Model Numbers DYNJ83972, UDI/DI (EA)10195327322694, UDI/DI (CS)40195327322695; vvv) Model Numbers DYNJ84130, UDI/DI (EA)10195327334550, UDI/DI (CS)40195327334551; www) Model Numbers DYNJ84252, UDI/DI (EA)10195327345570, UDI/DI (CS)40195327345571; xxx) Model Numbers DYNJ901075O, UDI/DI (EA)10195327052683, UDI/DI (CS)40195327052684; yyy) Model Numbers DYNJ901075P, UDI/DI (EA)10195327253554, UDI/DI (CS)40195327253555; zzz) Model Numbers DYNJ901745K, UDI/DI (EA)10193489482232, UDI/DI (CS)40193489482233; aaaa) Model Numbers DYNJ902259B, UDI/DI (EA)10193489919714, UDI/DI (CS)40193489919715; bbbb) Model Numbers DYNJ902261G, UDI/DI (EA)10193489919721, UDI/DI (CS)40193489919722; cccc) Model Numbers DYNJ902704P, UDI/DI (EA)10193489863376, UDI/DI (CS)40193489863377; dddd) Model Numbers DYNJ903451D, UDI/DI (EA)10193489667851, UDI/DI (CS)40193489667852; eeee) Model Numbers DYNJ903919J, UDI/DI (EA)10195327045906, UDI/DI (CS)40195327045907; ffff) Model Numbers DYNJ903919K, UDI/DI (EA)10195327218782, UDI/DI (CS)40195327218783; gggg) Model Numbers DYNJ903919L, UDI/DI (EA)10195327267056, UDI/DI (CS)40195327267057; hhhh) Model Numbers DYNJ904171F, UDI/DI (EA)10193489439243, UDI/DI (CS)40193489439244; iiii) Model Numbers DYNJ904401C, UDI/DI (EA)10193489348910, UDI/DI (CS)40193489348911; jjjj) Model Numbers DYNJ904984B, UDI/DI (EA)10193489812930, UDI/DI (CS)40193489812931; kkkk) Model Numbers DYNJ905079F, UDI/DI (EA)10195327209001, UDI/DI (CS)40195327209002; llll) Model Numbers DYNJ905285C, UDI/DI (EA)10193489947250, UDI/DI (CS)40193489947251; mmmm) Model Numbers DYNJ905291B, UDI/DI (EA)10193489950373, UDI/DI (CS)40193489950374; nnnn) Model Numbers DYNJ905291C, UDI/DI (EA)10195327062545, UDI/DI (CS)40195327062546; oooo) Model Numbers DYNJ905311I, UDI/DI (EA)10195327146214, UDI/DI (CS)40195327146215; pppp) Model Numbers DYNJ905516C, UDI/DI (EA)10193489967128, UDI/DI (CS)40193489967129; qqqq) Model Numbers DYNJ905516D, UDI/DI (EA)10195327147839, UDI/DI (CS)40195327147830; rrrr) Model Numbers DYNJ905516F, UDI/DI (EA)10195327247577, UDI/DI (CS)40195327247578; ssss) Model Numbers DYNJ905726C, UDI/DI (EA)10193489943375, UDI/DI (CS)40193489943376; tttt) Model Numbers DYNJ905726D, UDI/DI (EA)10195327161514, UDI/DI (CS)40195327161515; uuuu) Model Numbers DYNJ905744C, UDI/DI (EA)10195327162313, UDI/DI (CS)40195327162314; vvvv) Model Numbers DYNJ905859B, UDI/DI (EA)10193489417869, UDI/DI (CS)40193489417860; wwww) Model Numbers DYNJ905884A, UDI/DI (EA)10193489795448, UDI/DI (CS)40193489795449; xxxx) Model Numbers DYNJ906086B, UDI/DI (EA)10195327046354, UDI/DI (CS)40195327046355; yyyy) Model Numbers DYNJ906098A, UDI/DI (EA)10193489209457, UDI/DI (CS)40193489209458; zzzz) Model Numbers DYNJ906102F, UDI/DI (EA)10195327028268, UDI/DI (CS)40195327028269;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 13 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;

Z-2166-2023
Recall number
Z-2166-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796; b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340; c) Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274; d) Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875; e) Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306; f) Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238; g) Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206; h) Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053; i) Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838; j) Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849; k) Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833; l) Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272; m) Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406; n) Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195; o) Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510; p) Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358; q) Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737; r) Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520; s) Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608; t) Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434; u) Model Numbers DYNJ907915, UDI/DI (EA)10193489943689, UDI/DI (CS)40193489943680; v) Model Numbers DYNJ907975, UDI/DI (EA)10193489965605, UDI/DI (CS)40193489965606; w) Model Numbers DYNJ907975A, UDI/DI (EA)10195327155070, UDI/DI (CS)40195327155071; x) Model Numbers DYNJ907975B, UDI/DI (EA)10195327376291, UDI/DI (CS)40195327376292; y) Model Numbers DYNJ908074B, UDI/DI (EA)10195327172688, UDI/DI (CS)40195327172689; z) Model Numbers DYNJ908121B, UDI/DI (EA)10195327095710, UDI/DI (CS)40195327095711; aa) Model Numbers DYNJ908179A, UDI/DI (EA)10195327222574, UDI/DI (CS)40195327222575; bb) Model Numbers DYNJ908563, UDI/DI (EA)10195327086428, UDI/DI (CS)40195327086429; cc) Model Numbers DYNJ908646, UDI/DI (EA)10195327123956, UDI/DI (CS)40195327123957; dd) Model Numbers DYNJ908646A, UDI/DI (EA)10195327314965, UDI/DI (CS)40195327314966; ee) Model Numbers DYNJ908880, UDI/DI (EA)10195327203436, UDI/DI (CS)40195327203437; ff) Model Numbers DYNJ908880A, UDI/DI (EA)10195327259198, UDI/DI (CS)40195327259199; gg) Model Numbers DYNJ909091, UDI/DI (EA)10195327268602, UDI/DI (CS)40195327268603; hh) Model Numbers DYNJ909253, UDI/DI (EA)10195327317027, UDI/DI (CS)40195327317028; ii) Model Numbers DYNJ909270, UDI/DI (EA)10195327317171, UDI/DI (CS)40195327317172; jj) Model Numbers DYNJ9372030G, UDI/DI (EA)10195327025434, UDI/DI (CS)40195327025435; kk) Model Numbers DYNJ9718008AS, UDI/DI (EA)10193489263121, UDI/DI (CS)40193489263122; ll) Model Numbers DYNJV0275M, UDI/DI (EA)10195327018627, UDI/DI (CS)40195327018628; mm) Model Numbers DYNJVB1302A, UDI/DI (EA)10193489928341, UDI/DI (CS)40193489928342; nn) Model Numbers DYNJVB1307, UDI/DI (EA)10193489872910, UDI/DI (CS)40193489872911; oo) Model Numbers DYNJVB1307A, UDI/DI (EA)10195327227333, UDI/DI (CS)40195327227334; pp) Model Numbers DYNJVB91063C, UDI/DI (EA)10195327257125, UDI/DI (CS)40195327257126; qq) Model Numbers DYNJVB91067, UDI/DI (EA)10193489801538, UDI/DI (CS)40193489801539; rr) Model Numbers PAIN1423A, UDI/DI (EA)10193489201826, UDI/DI (CS)40193489201827; ss) Model Numbers PHS151095000, UDI/DI (EA)10889942035601, UDI/DI (CS)40889942035602; tt) Model Numbers PHS41732B, UDI/DI (EA)10193489784817, UDI/DI (CS)40193489784818; uu) Model Numbers PICCNC0010, UDI/DI (EA)10195327231170, UDI/DI (CS)40195327231171; vv) Model Numbers TVS4000L, UDI/DI (EA)10195327223540, UDI/DI (CS)40195327223541;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 14 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA2482; i) ULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669; j) I.R. PICC PACK, Model Number DYNDA2759; k) IR SONO PACK, Model Number DYNDA3010; l) NEONATAL PICC LINE TRAY, Model Number DYNDC2120B; m) PICC SUPPLEMENTAL KIT, Model Number DYNDC2373A; n) CENTRAL LINE KIT, Model Number DYNDC2582A; o) CENTRAL LINE KIT UTMB, Model Number DYNDC3061; p) FNA TRAY, Model Number DYNDH1123B; q) CVL PACK, Model Number DYNJ00281O; r) CENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O; s) CENTRAL LINE PACK-LF, Model Number DYNJ0220136Q; t) PICC LINE PACK-LF, Model Number DYNJ0235859I; u) PICC LINE PACK-LF, Model Number DYNJ0235859J; v) PICC LINE PACK-LF, Model Number DYNJ0235859K; w) PICC LINE PACK, Model Number DYNJ04592K; x) PICC LINE PACK-LF, Model Number DYNJ0678523N; y) PICC LINE PACK-LF, Model Number DYNJ0855123N; z) PICC INSERTION PACK-LF, Model Number DYNJ0880659F; aa) PICC PACK-LF, Model Number DYNJ0940720D; bb) VENOUS ACCESS PACK-LF, Model Number DYNJ09895R; cc) PICC PACK-LF, Model Number DYNJ17086A; dd) VENOUS ACCESS TRAY, Model Number DYNJ20094L; ee) PICC LINE PACK-LF, Model Number DYNJ21575I; ff) CENTRAL LINE PACK, Model Number DYNJ30087C; gg) PICC LINE PACK, Model Number DYNJ30233C; hh) PICC PACK, Model Number DYNJ30566B; ii) CENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G; jj) PICC TRAY, Model Number DYNJ33005F; kk) PICC TRAY, Model Number DYNJ33005G; ll) PICC LINE INSERTION TRAY, Model Number DYNJ34241; mm) PICC PACK-LF, Model Number DYNJ35000I; nn) PORT PACK, Model Number DYNJ35163C; oo) PICC TRAY-LF, Model Number DYNJ35272; pp) PICC LINE INSERTION PACK, Model Number DYNJ38868K; qq) PICC LINE INSERTION PACK, Model Number DYNJ38868L; rr) PICC ACCESSORY TRAY, Model Number DYNJ39039M; ss) CVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B; tt) PICC INSERTION PACK MH-LF, Model Number DYNJ40206B; uu) ACCESS PICC PACK, Model Number DYNJ40682B; vv) PHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C; ww) MV-IR-PICC PACK-LF, Model Number DYNJ41554C; xx) PICC TRAY, Model Number DYNJ41648; yy) CENTRAL LINE TRAY, Model Number DYNJ42902C; zz) CENTRAL LINE TRAY, Model Number DYNJ42902D; aaa) VENOUS PACK, Model Number DYNJ43168; bbb) VENOUS PACK, Model Number DYNJ43168A; ccc) VENOUS PACK, Model Number DYNJ43168B; ddd) IR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G; eee) WEST VALLEY PICC LINE PACK, Model Number DYNJ43975A; fff) VENOUS LIGATION PACK, Model Number DYNJ43981G; ggg) VEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C; hhh) VENOUS ABLATION, Model Number DYNJ44904C; iii) PICC LINE PACK, Model Number DYNJ47037C; jjj) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B; kkk) CENTRAL LINE PACK, Model Number DYNJ48096B; lll) PICC PACK-LF, Model Number DYNJ48120B; mmm) AV FISTULA PACK-LF, Model Number DYNJ48428C; nnn) VIEN CLOSURE, Model Number DYNJ49180A; ooo) ARTERIAL LINE PACK, Model Number DYNJ49235D; ppp) PICC PACK, Model Number DYNJ52255; qqq) PICC LINE TRAY, Model Number DYNJ52688B; rrr) PICC LINE TRAY, Model Number DYNJ52688C; sss) CENTRAL LINE INSERTION KIT, Model Number DYNJ52894A; ttt) ARTERIOGRAM PACK, Model Number DYNJ53095A; uuu) ENDOVENOUS ABLATION PACK, Model Number DYNJ53435D; vvv) MID HUDSON PICC LINE PACK, Model Number DYNJ53618A; www) MSB BEDSIDE TRAY, Model Number DYNJ54670; xxx) LEE VEIN PACK, Model Number DYNJ54906C; yyy) ARTERIOGRAM PACK, Model Number DYNJ55169G; zzz) PICC LINE PACK, Model Number DYNJ55170B; aaaa) PICC LINE PACK, M

Z-2167-2023
Recall number
Z-2167-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
269985 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART995, UDI/DI (EA) 10193489190502,UDI/DI (CS) 40193489190503; b) Model Number ARTNC145, UDI/DI (EA) 10195327306762,UDI/DI (CS) 40195327306763; c) Model Number CVI4705, UDI/DI (EA) 10193489832372,UDI/DI (CS) 40193489832373; d) Model Number CVI4805, UDI/DI (EA) 10195327068714,UDI/DI (CS) 40195327068715; e) Model Number CVI4865, UDI/DI (EA) 10195327235260,UDI/DI (CS) 40195327235261; f) Model Number CVI4950A, UDI/DI (EA) 10195327351960,UDI/DI (CS) 40195327351961; g) Model Number DT22260, UDI/DI (EA) 10653160329190,UDI/DI (CS) 40653160329191; h) Model Number DYNDA2482, UDI/DI (EA) 10193489351606,UDI/DI (CS) 40193489351607; i) Model Number DYNDA2669, UDI/DI (EA) 10193489465426,UDI/DI (CS) 40193489465427; j) Model Number DYNDA2759, UDI/DI (EA) 10193489488197,UDI/DI (CS) 40193489488198; k) Model Number DYNDA3010, UDI/DI (EA) 10195327282301,UDI/DI (CS) 40195327282302; l) Model Number DYNDC2120B, UDI/DI (EA) 10193489363357,UDI/DI (CS) 40193489363358; m) Model Number DYNDC2373A, UDI/DI (EA) 10889942492206,UDI/DI (CS) 40889942492207; n) Model Number DYNDC2582A, UDI/DI (EA) 10193489349399,UDI/DI (CS) 40193489349390; o) Model Number DYNDC3061, UDI/DI (EA) 10193489495812,UDI/DI (CS) 40193489495813; p) Model Number DYNDH1123B, UDI/DI (EA) 10193489465556,UDI/DI (CS) 40193489465557; q) Model Number DYNJ00281O, UDI/DI (EA) 10193489962963,UDI/DI (CS) 40193489962964; r) Model Number DYNJ0214541O, UDI/DI (EA) 10195327088880,UDI/DI (CS) 40195327088881; s) Model Number DYNJ0220136Q, UDI/DI (EA) 10193489823486,UDI/DI (CS) 40193489823487; t) Model Number DYNJ0235859I, UDI/DI (EA) 10193489421347,UDI/DI (CS) 40193489421348; u) Model Number DYNJ0235859J, UDI/DI (EA) 10195327069278,UDI/DI (CS) 40195327069279; v) Model Number DYNJ0235859K, UDI/DI (EA) 10195327243210,UDI/DI (CS) 40195327243211; w) Model Number DYNJ04592K, UDI/DI (EA) 10193489215205,UDI/DI (CS) 40193489215206; x) Model Number DYNJ0678523N, UDI/DI (EA) 10193489994049,UDI/DI (CS) 40193489994040; y) Model Number DYNJ0855123N, UDI/DI (EA) 10195327094881,UDI/DI (CS) 40195327094882; z) Model Number DYNJ0880659F, UDI/DI (EA) 10195327111496,UDI/DI (CS) 40195327111497; aa) Model Number DYNJ0940720D, UDI/DI (EA) 10889942550951,UDI/DI (CS) 40889942550952; bb) Model Number DYNJ09895R, UDI/DI (EA) 10195327264529,UDI/DI (CS) 40195327264520; cc) Model Number DYNJ17086A, UDI/DI (EA) 10884389064306,UDI/DI (CS) 40884389064307; dd) Model Number DYNJ20094L, UDI/DI (EA) 10195327212902,UDI/DI (CS) 40195327212903; ee) Model Number DYNJ21575I, UDI/DI (EA) 10195327009670,UDI/DI (CS) 40195327009671; ff) Model Number DYNJ30087C, UDI/DI (EA) 10889942754144,UDI/DI (CS) 40889942754145; gg) Model Number DYNJ30233C, UDI/DI (EA) 10193489382570,UDI/DI (CS) 40193489382571; hh) Model Number DYNJ30566B, UDI/DI (EA) 10889942375523,UDI/DI (CS) 40889942375524; ii) Model Number DYNJ32358G, UDI/DI (EA) 10889942526475,UDI/DI (CS) 40889942526476; jj) Model Number DYNJ33005F, UDI/DI (EA) 10193489954135,UDI/DI (CS) 40193489954136; kk) Model Number DYNJ33005G, UDI/DI (EA) 10195327319663,UDI/DI (CS) 40195327319664; ll) Model Number DYNJ34241, UDI/DI (EA) 10884389335864,UDI/DI (CS) 40884389335865; mm) Model Number DYNJ35000I, UDI/DI (EA) 10193489261646,UDI/DI (CS) 40193489261647; nn) Model Number DYNJ35163C, UDI/DI (EA) 10889942494682,UDI/DI (CS) 40889942494683; oo) Model Number DYNJ35272, UDI/DI (EA) 10884389428269,UDI/DI (CS) 40884389428260; pp) Model Number DYNJ38868K, UDI/DI (EA) 10193489657609,UDI/DI (CS) 40193489657600; qq) Model Number DYNJ38868L, UDI/DI (EA) 10195327224776,UDI/DI (CS) 40195327224777; rr) Model Number DYNJ39039M, UDI/DI (EA) 10193489898507,UDI/DI (CS) 40193489898508; ss) Model Number DYNJ40204B, UDI/DI (EA) 10195327178451,UDI/DI (CS) 40195327178452; tt) Model Number DYNJ40206B, UDI/DI (EA) 10195327176440,UDI/DI (CS) 40195327176441; uu) Model Number DYNJ40682B, UDI/DI (EA) 10889942267217,UDI/DI (CS) 40889942267218; vv) Model Number DYNJ40990C, UDI/DI (EA) 10889942024377,UDI/DI (CS) 40889942024378; ww) Model Number DYNJ41554C, UDI/DI (EA) 10889942811328,UDI/DI (CS) 40889942811329; xx) Model Number DYNJ41648, UDI/DI (EA) 10884389909171,UDI/DI (CS) 40884389909172; yy) Model Number DYNJ42902C, UDI/DI (EA) 10195327084684,UDI/DI (CS) 40195327084685; zz) Model Number DYNJ42902D, UDI/DI (EA) 10195327171100,UDI/DI (CS) 40195327171101; aaa) Model Number DYNJ43168, UDI/DI (EA) 10888277034891,UDI/DI (CS) 40888277034892; bbb) Model Number DYNJ43168A, UDI/DI (EA) 10195327084707,UDI/DI (CS) 40195327084708; ccc) Model Number DYNJ43168B, UDI/DI (EA) 10195327224523,UDI/DI (CS) 40195327224524; ddd) Model Number DYNJ43267G, UDI/DI (EA) 10195327288808,UDI/DI (CS) 40195327288809; eee) Model Number DYNJ43975A, UDI/DI (EA) 10888277882447,UDI/DI (CS) 40888277882448; fff) Model Number DYNJ43981G, UDI/DI (EA) 10193489223538,UDI/DI (CS) 40193489223539; ggg) Model Number DYNJ44737C, UDI/DI (EA) 10195327277871,UDI/DI (CS) 40195327277872; hhh) Model Number DYNJ44904C, UDI/DI (EA) 10193489858679,UDI/DI (CS) 40193489858670; iii) Model Number DYNJ47037C, UDI/DI (EA) 10193489616002,UDI/DI (CS) 40193489616003; jjj) Model Number DYNJ47717B, UDI/DI (EA) 10195327355302,UDI/DI (CS) 40195327355303; kkk) Model Number DYNJ48096B, UDI/DI (EA) 10888277939318,UDI/DI (CS) 40888277939319; lll) Model Number DYNJ48120B, UDI/DI (EA) 10888277894877,UDI/DI (CS) 40888277894878; mmm) Model Number DYNJ48428C, UDI/DI (EA) 10193489702477,UDI/DI (CS) 40193489702478; nnn) Model Number DYNJ49180A, UDI/DI (EA) 10888277863569,UDI/DI (CS) 40888277863560; ooo) Model Number DYNJ49235D, UDI/DI (EA) 10193489894332,UDI/DI (CS) 40193489894333; ppp) Model Number DYNJ52255, UDI/DI (EA) 10889942253708,UDI/DI (CS) 40889942253709; qqq) Model Number DYNJ52688B, UDI/DI (EA) 10193489452471,UDI/DI (CS) 40193489452472; rrr) Model Number DYNJ52688C, UDI/DI (EA) 10195327301026,UDI/DI (CS) 40195327301027; sss) Model Number DYNJ52894A, UDI/DI (EA) 10889942437542,UDI/DI (CS) 40889942437543; ttt) Model Number DYNJ53095A, UDI/DI (EA) 10195327148720,UDI/DI (CS) 40195327148721; uuu) Model Number DYNJ53435D, UDI/DI (EA) 10195327196448,UDI/DI (CS) 40195327196449; vvv) Model Number DYNJ53618A, UDI/DI (EA) 10889942492497,UDI/DI (CS) 40889942492498; www) Model Number DYNJ54670, UDI/DI (EA) 10889942499571,UDI/DI (CS) 40889942499572; xxx) Model Number DYNJ54906C, UDI/DI (EA) 10195327188764,UDI/DI (CS) 40195327188765; yyy) Model Number DYNJ55169G, UDI/DI (EA) 10193489967562,UDI/DI (CS) 40193489967563; zzz) Model Number DYNJ55170B, UDI/DI (EA) 10193489967579,UDI/DI (CS) 40193489967570; aaaa) Model Number DYNJ55170C, UDI/DI (EA) 10195327135355,UDI/DI (CS) 40195327135356; bbbb) Model Number DYNJ55546D, UDI/DI (EA) 10195327056520,UDI/DI (CS) 40195327056521; cccc) Model Number DYNJ56029A, UDI/DI (EA) 10195327347826,UDI/DI (CS) 40195327347827; dddd) Model Number DYNJ56857C, UDI/DI (EA) 10193489967586,UDI/DI (CS) 40193489967587; eeee) Model Number DYNJ56857D, UDI/DI (EA) 10195327280963,UDI/DI (CS) 40195327280964; ffff) Model Number DYNJ57112, UDI/DI (EA) 10889942721597,UDI/DI (CS) 40889942721598; gggg) Model Number DYNJ57793A, UDI/DI (EA) 10193489846027,UDI/DI (CS) 40193489846028; hhhh) Model Number DYNJ59246A, UDI/DI (EA) 10195327039110,UDI/DI (CS) 40195327039111; iiii) Model Number DYNJ59751B, UDI/DI (EA) 10193489695915,UDI/DI (CS) 40193489695916; jjjj) Model Number DYNJ60038A, UDI/DI (EA) 10195327038335,UDI/DI (CS) 40195327038336; kkkk) Model Number DYNJ60329A, UDI/DI (EA) 10193489972221,UDI/DI (CS) 40193489972222; llll) Model Number DYNJ60990B, UDI/DI (EA) 10193489921700,UDI/DI (CS) 40193489921701; mmmm) Model Number DYNJ62038B, UDI/DI (EA) 10193489898491,UDI/DI (CS) 40193489898492; nnnn) Model Number DYNJ62711A, UDI/DI (EA) 10193489233018,UDI/DI (CS) 40193489233019; oooo) Model Number DYNJ62889A, UDI/DI (EA) 10193489971125,UDI/DI (CS) 40193489971126; pppp) Model Number DYNJ62889B, UDI/DI (EA) 10195327030957,UDI/DI (CS) 40195327030958; qqqq) Model Number DYNJ63162, UDI/DI (EA) 10193489720891,UDI/DI (CS) 40193489720892; rrrr) Model Number DYNJ63213, UDI/DI (EA) 10193489728217,UDI/DI (CS) 40193489728218; ssss) Model Number DYNJ63268C, UDI/DI (EA) 10195327077167,UDI/DI (CS) 40195327077168; tttt) Model Number DYNJ63268D, UDI/DI (EA) 10195327132217,UDI/DI (CS) 40195327132218; uuuu) Model Number DYNJ63268F, UDI/DI (EA) 10195327297114,UDI/DI (CS) 40195327297115; vvvv) Model Number DYNJ63590, UDI/DI (EA) 10193489769180,UDI/DI (CS) 40193489769181; wwww) Model Number DYNJ64141A, UDI/DI (EA) 10195327279578,UDI/DI (CS) 40195327279579; xxxx) Model Number DYNJ64190B, UDI/DI (EA) 10195327281281,UDI/DI (CS) 40195327281282; yyyy) Model Number DYNJ64249A, UDI/DI (EA) 10193489381368,UDI/DI (CS) 40193489381369; zzzz) Model Number DYNJ64337, UDI/DI (EA) 10193489800289,UDI/DI (CS) 40193489800280;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 15 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827; f) PICC PACK, Model Number DYNJ65838; g) JVL-PACK PICC, Model Number DYNJ66062; h) FISTULAGRAM PACK, Model Number DYNJ66259; i) VEIN PACK-LF, Model Number DYNJ66271B; j) VEIN PACK-LF, Model Number DYNJ66271D; k) VASCULAR PACK, Model Number DYNJ66356F; l) VENOUS PACK, Model Number DYNJ66499A; m) VENOUS PACK, Model Number DYNJ66499B; n) VEIN PACK, Model Number DYNJ66743B; o) AV FISTULA PACK, Model Number DYNJ66916; p) VEIN ABLATION PLUS W CHL, Model Number DYNJ67115A; q) PICC INSERTION TRAY, Model Number DYNJ67415; r) AFCH CVC INSERTION, Model Number DYNJ67534; s) ENS PICC LINE-HEJ-LF, Model Number DYNJ67606; t) VEIN TRAY, Model Number DYNJ69012A; u) PICC PACK, Model Number DYNJ69088; v) PICC PACK, Model Number DYNJ69088A; w) VEIN PACK, Model Number DYNJ69091A; x) VEIN PACK, Model Number DYNJ69091B; y) VEIN PACK, Model Number DYNJ69177; z) VEIN ABLATION KIT, Model Number DYNJ69272; aa) VEIN ABLATION PACK, Model Number DYNJ69288; bb) BASIC VEIN PACK, Model Number DYNJ69426; cc) VASCULAR VEIN PACK, Model Number DYNJ69769; dd) BCH VEIN ABLATION, Model Number DYNJ69796; ee) VEIN PACK, Model Number DYNJ69942A; ff) FISTULA SAVANNAH PACK, Model Number DYNJ69943; gg) VEIN CLOSURE PACK, Model Number DYNJ69976; hh) VEIN CLOSURE PACK, Model Number DYNJ69976A; ii) VENCLOSE PROCEDURE PACK, Model Number DYNJ80123; jj) VENOUS PACK, Model Number DYNJ80169; kk) VENOUS PACK, Model Number DYNJ80169A; ll) CVR ENDOVENOUS PACK, Model Number DYNJ80643; mm) VENOUS PACK, Model Number DYNJ80692; nn) VENOUS PACK, Model Number DYNJ80692A; oo) VEIN PACK, Model Number DYNJ81120; pp) VEIN PROCEDURE PACK, Model Number DYNJ81177; qq) VEIN PACK, Model Number DYNJ81212A; rr) SUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267; ss) OR VASCULAR ANGIO PACK, Model Number DYNJ81592; tt) PARAGON VEIN PACK, Model Number DYNJ81669; uu) PARAGON VEIN PACK, Model Number DYNJ81669B; vv) ANGIOGRAM-DECH-LF, Model Number DYNJ81725; ww) PICC-DECH-LF, Model Number DYNJ81726; xx) VEIN CLOSURE PACK, Model Number DYNJ81834; yy) VEIN PACK, Model Number DYNJ82033; zz) VEIN PACK, Model Number DYNJ82033A; aaa) SUPERFICIAL VENOUS PACK, Model Number DYNJ82100; bbb) SUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101; ccc) VEIN PROCEDURE TRAY, Model Number DYNJ82581; ddd) VARICOSE VEIN PACK, Model Number DYNJ82884; eee) VARICOSE VEIN PACK, Model Number DYNJ82885; fff) LASER VEIN EC PACK, Model Number DYNJ82951; ggg) SUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989; hhh) PORT DIALYSIS PACK, Model Number DYNJ83087; iii) DEXMED ACCESS PACK, Model Number DYNJ83148; jjj) VEIN TRAY, Model Number DYNJ83384A; kkk) RADIO VEIN ABLATION PACK, Model Number DYNJ83534; lll) VEIN PACK, Model Number DYNJ83747; mmm) VEIN ABLATION PACK, Model Number DYNJ83846; nnn) VEIN PACK, Model Number DYNJ83914; ooo) VEIN PACK, Model Number DYNJ83935; ppp) VEIN ABLATION PACK, Model Number DYNJ83974; qqq) VENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I; rrr) VASCULAR ACCESS-LF, Model Number DYNJ905285D; sss) GENERAL AV FISTULA, Model Number DYNJ906011B; ttt) KIT VEIN ABLATION, Model Number DYNJ907381; uuu) OPEN VASCULAR UE, Model Number DYNJ907858; vvv) PICC LINE TRAY-LF, Model Number DYNJT2272J; www) PICC LINE TRAY-LF, Model Number DYNJT2272K; xxx) PICC CUSTOM PACK, Model Number GSS584Q; yyy) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A; zzz) PEDS/ NICU LINE KIT, Model Number MNS13555; aaaa) ER CENTRAL LINE KIT, Model Number P155508D; bbbb) PICC INSERTION TRAY, Model Number PICC0018; cccc) PICC TRAY, Model Number PICCNC0008; dddd) PQ PICC LINE PACK, Model Number PICCNC0013; eeee) STANDARD PICC II-LF, Model Number

Z-2168-2023
Recall number
Z-2168-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144; b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847; c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810; d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825; e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490; f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262; g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218; h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486; i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918; j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740; k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013; l) Model Number DYNJ66499A, UDI/DI (EA) 10193489977523,UDI/DI (CS) 40193489977524; m) Model Number DYNJ66499B, UDI/DI (EA) 10195327242107,UDI/DI (CS) 40195327242108; n) Model Number DYNJ66743B, UDI/DI (EA) 10193489949797,UDI/DI (CS) 40193489949798; o) Model Number DYNJ66916, UDI/DI (EA) 10193489387650,UDI/DI (CS) 40193489387651; p) Model Number DYNJ67115A, UDI/DI (EA) 10195327091880,UDI/DI (CS) 40195327091881; q) Model Number DYNJ67415, UDI/DI (EA) 10193489930887,UDI/DI (CS) 40193489930888; r) Model Number DYNJ67534, UDI/DI (EA) 10193489409321,UDI/DI (CS) 40193489409322; s) Model Number DYNJ67606, UDI/DI (EA) 10193489421675,UDI/DI (CS) 40193489421676; t) Model Number DYNJ69012A, UDI/DI (EA) 10195327331719,UDI/DI (CS) 40195327331710; u) Model Number DYNJ69088, UDI/DI (EA) 10193489883619,UDI/DI (CS) 40193489883610; v) Model Number DYNJ69088A, UDI/DI (EA) 10193489975246,UDI/DI (CS) 40193489975247; w) Model Number DYNJ69091A, UDI/DI (EA) 10193489969764,UDI/DI (CS) 40193489969765; x) Model Number DYNJ69091B, UDI/DI (EA) 10195327178994,UDI/DI (CS) 40195327178995; y) Model Number DYNJ69177, UDI/DI (EA) 10193489902198,UDI/DI (CS) 40193489902199; z) Model Number DYNJ69272, UDI/DI (EA) 10193489920338,UDI/DI (CS) 40193489920339; aa) Model Number DYNJ69288, UDI/DI (EA) 10193489922677,UDI/DI (CS) 40193489922678; bb) Model Number DYNJ69426, UDI/DI (EA) 10193489939392,UDI/DI (CS) 40193489939393; cc) Model Number DYNJ69769, UDI/DI (EA) 10193489977790,UDI/DI (CS) 40193489977791; dd) Model Number DYNJ69796, UDI/DI (EA) 10193489979350,UDI/DI (CS) 40193489979351; ee) Model Number DYNJ69942A, UDI/DI (EA) 10195327284626,UDI/DI (CS) 40195327284627; ff) Model Number DYNJ69943, UDI/DI (EA) 10193489998443,UDI/DI (CS) 40193489998444; gg) Model Number DYNJ69976, UDI/DI (EA) 10195327001308,UDI/DI (CS) 40195327001309; hh) Model Number DYNJ69976A, UDI/DI (EA) 10195327130398,UDI/DI (CS) 40195327130399; ii) Model Number DYNJ80123, UDI/DI (EA) 10195327009182,UDI/DI (CS) 40195327009183; jj) Model Number DYNJ80169, UDI/DI (EA) 10195327013448,UDI/DI (CS) 40195327013449; kk) Model Number DYNJ80169A, UDI/DI (EA) 10195327169749,UDI/DI (CS) 40195327169740; ll) Model Number DYNJ80643, UDI/DI (EA) 10195327055790,UDI/DI (CS) 40195327055791; mm) Model Number DYNJ80692, UDI/DI (EA) 10195327065546,UDI/DI (CS) 40195327065547; nn) Model Number DYNJ80692A, UDI/DI (EA) 10195327340827,UDI/DI (CS) 40195327340828; oo) Model Number DYNJ81120, UDI/DI (EA) 10195327085889,UDI/DI (CS) 40195327085880; pp) Model Number DYNJ81177, UDI/DI (EA) 10195327089610,UDI/DI (CS) 40195327089611; qq) Model Number DYNJ81212A, UDI/DI (EA) 10195327159863,UDI/DI (CS) 40195327159864; rr) Model Number DYNJ81267, UDI/DI (EA) 10195327101442,UDI/DI (CS) 40195327101443; ss) Model Number DYNJ81592, UDI/DI (EA) 10195327123772,UDI/DI (CS) 40195327123773; tt) Model Number DYNJ81669, UDI/DI (EA) 10195327132323,UDI/DI (CS) 40195327132324; uu) Model Number DYNJ81669B, UDI/DI (EA) 10195327253431,UDI/DI (CS) 40195327253432; vv) Model Number DYNJ81725, UDI/DI (EA) 10195327136758,UDI/DI (CS) 40195327136759; ww) Model Number DYNJ81726, UDI/DI (EA) 10195327136772,UDI/DI (CS) 40195327136773; xx) Model Number DYNJ81834, UDI/DI (EA) 10195327147853,UDI/DI (CS) 40195327147854; yy) Model Number DYNJ82033, UDI/DI (EA) 10195327162979,UDI/DI (CS) 40195327162970; zz) Model Number DYNJ82033A, UDI/DI (EA) 10195327271442,UDI/DI (CS) 40195327271443; aaa) Model Number DYNJ82100, UDI/DI (EA) 10195327170592,UDI/DI (CS) 40195327170593; bbb) Model Number DYNJ82101, UDI/DI (EA) 10195327170585,UDI/DI (CS) 40195327170586; ccc) Model Number DYNJ82581, UDI/DI (EA) 10195327198657,UDI/DI (CS) 40195327198658; ddd) Model Number DYNJ82884, UDI/DI (EA) 10195327215996,UDI/DI (CS) 40195327215997; eee) Model Number DYNJ82885, UDI/DI (EA) 10195327216009,UDI/DI (CS) 40195327216000; fff) Model Number DYNJ82951, UDI/DI (EA) 10195327218973,UDI/DI (CS) 40195327218974; ggg) Model Number DYNJ82989, UDI/DI (EA) 10195327221768,UDI/DI (CS) 40195327221769; hhh) Model Number DYNJ83087, UDI/DI (EA) 10195327231255,UDI/DI (CS) 40195327231256; iii) Model Number DYNJ83148, UDI/DI (EA) 10195327235512,UDI/DI (CS) 40195327235513; jjj) Model Number DYNJ83384A, UDI/DI (EA) 10195327304812,UDI/DI (CS) 40195327304813; kkk) Model Number DYNJ83534, UDI/DI (EA) 10195327276713,UDI/DI (CS) 40195327276714; lll) Model Number DYNJ83747, UDI/DI (EA) 10195327300739,UDI/DI (CS) 40195327300730; mmm) Model Number DYNJ83846, UDI/DI (EA) 10195327311490,UDI/DI (CS) 40195327311491; nnn) Model Number DYNJ83914, UDI/DI (EA) 10195327313128,UDI/DI (CS) 40195327313129; ooo) Model Number DYNJ83935, UDI/DI (EA) 10195327318543,UDI/DI (CS) 40195327318544; ppp) Model Number DYNJ83974, UDI/DI (EA) 10195327323141,UDI/DI (CS) 40195327323142; qqq) Model Number DYNJ902602I, UDI/DI (EA) 10193489892567,UDI/DI (CS) 40193489892568; rrr) Model Number DYNJ905285D, UDI/DI (EA) 10195327062668,UDI/DI (CS) 40195327062669; sss) Model Number DYNJ906011B, UDI/DI (EA) 10193489411232,UDI/DI (CS) 40193489411233; ttt) Model Number DYNJ907381, UDI/DI (EA) 10193489900774,UDI/DI (CS) 40193489900775; uuu) Model Number DYNJ907858, UDI/DI (EA) 10193489909357,UDI/DI (CS) 40193489909358; vvv) Model Number DYNJT2272J, UDI/DI (EA) 10889942426324,UDI/DI (CS) 40889942426325; www) Model Number DYNJT2272K, UDI/DI (EA) 10195327250676,UDI/DI (CS) 40195327250677; xxx) Model Number GSS584Q, UDI/DI (EA) 10193489941029,UDI/DI (CS) 40193489941020; yyy) Model Number IVS3635A, UDI/DI (EA) 10193489362916,UDI/DI (CS) 40193489362917; zzz) Model Number MNS13555, UDI/DI (EA) 10653160991953,UDI/DI (CS) 40653160991954; aaaa) Model Number P155508D, UDI/DI (EA) 10193489899061,UDI/DI (CS) 40193489899062; bbbb) Model Number PICC0018, UDI/DI (EA) 10195327327392,UDI/DI (CS) 40195327327393; cccc) Model Number PICCNC0008, UDI/DI (EA) 10195327221584,UDI/DI (CS) 40195327221585; dddd) Model Number PICCNC0013, UDI/DI (EA) 10195327311223,UDI/DI (CS) 40195327311224; eeee) Model Number PICCNC002, UDI/DI (EA) 10193489877199,UDI/DI (CS) 40193489877190; ffff) Model Number VC-PP-6F12, UDI/DI (EA) 10193489576658,UDI/DI (CS) 40193489576659; gggg) Model Number VC-PPH-6F12A, UDI/DI (EA) 10193489423105,UDI/DI (CS) 40193489423106; hhhh) Model Number VC-PPH-6F7A, UDI/DI (EA) 10193489423099,UDI/DI (CS) 40193489423090; iiii) Model Number VC-PPM-12F, UDI/DI (EA) 10193489422689,UDI/DI (CS) 40193489422680;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 16 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;

Z-2169-2023
Recall number
Z-2169-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
770147 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS840214Q, UDI/DI (EA) 10195327289904, UDI/DI (CS) 40195327289905; b) Model Number DYNDA2418, UDI/DI (EA) 10193489378214, UDI/DI (CS) 40193489378215; c) Model Number DYNJ0365463J, UDI/DI (EA) 10193489783872, UDI/DI (CS) 40193489783873; d) Model Number DYNJ24459P, UDI/DI (EA) 10193489355345, UDI/DI (CS) 40193489355346; e) Model Number DYNJ40629B, UDI/DI (EA) 10888277778696, UDI/DI (CS) 40888277778697; f) Model Number DYNJ44210B, UDI/DI (EA) 10193489306859, UDI/DI (CS) 40193489306850; g) Model Number DYNJ47716C, UDI/DI (EA) 10195327355296, UDI/DI (CS) 40195327355297; h) Model Number DYNJ48520, UDI/DI (EA) 10888277903463, UDI/DI (CS) 40888277903464; i) Model Number DYNJ53059A, UDI/DI (EA) 10889942415113, UDI/DI (CS) 40889942415114; j) Model Number DYNJ59813, UDI/DI (EA) 10888277786455, UDI/DI (CS) 40888277786456; k) Model Number DYNJ61747C, UDI/DI (EA) 10193489365030, UDI/DI (CS) 40193489365031; l) Model Number DYNJ68027A, UDI/DI (EA) 10195327351144, UDI/DI (CS) 40195327351145; m) Model Number DYNJ81410B, UDI/DI (EA) 10195327320829, UDI/DI (CS) 40195327320820; n) Model Number DYNJ82517, UDI/DI (EA) 10195327198640, UDI/DI (CS) 40195327198641; o) Model Number DYNJ83966, UDI/DI (EA) 10195327320423, UDI/DI (CS) 40195327320424; p) Model Number DYNJ906915, UDI/DI (EA) 10193489280371, UDI/DI (CS) 40193489280372; q) Model Number DYNJ908046C, UDI/DI (EA) 10195327313494, UDI/DI (CS) 40195327313495; r) Model Number PHS751646C, UDI/DI (EA) 10889942245352, UDI/DI (CS) 40889942245353; s) Model Number PHS751646D, UDI/DI (EA) 10195327196806, UDI/DI (CS) 40195327196807;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 17 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;

Z-2170-2023
Recall number
Z-2170-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
47185 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDA1224B, UDI/DI (EA) 10193489468519, UDI/DI (CS) 40193489468510; b) Model Number DYNDH1121C, UDI/DI (EA) 10193489468656, UDI/DI (CS) 40193489468657; c) Model Number DYNDH1124, UDI/DI (EA) 10889942303274, UDI/DI (CS) 40889942303275; d) Model Number DYNDH1147A, UDI/DI (EA) 10193489348798, UDI/DI (CS) 40193489348799; e) Model Number DYNDH1266, UDI/DI (EA) 10889942670451, UDI/DI (CS) 40889942670452; f) Model Number DYNDH1345A, UDI/DI (EA) 10888277732933, UDI/DI (CS) 40888277732934; g) Model Number DYNDH1496A, UDI/DI (EA) 10193489825312, UDI/DI (CS) 40193489825313; h) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 40193489197083; i) Model Number DYNDH1542B, UDI/DI (EA) 10195327251475, UDI/DI (CS) 40195327251476; j) Model Number DYNDH1670, UDI/DI (EA) 10195327010683, UDI/DI (CS) 40195327010684; k) Model Number DYNDH1677, UDI/DI (EA) 10195327044480, UDI/DI (CS) 40195327044481; l) Model Number DYNDH1748, UDI/DI (EA) 10195327164744, UDI/DI (CS) 40195327164745; m) Model Number DYNDH1750, UDI/DI (EA) 10195327166427, UDI/DI (CS) 40195327166428; n) Model Number DYNDH1750A, UDI/DI (EA) 10195327337872, UDI/DI (CS) 40195327337873; o) Model Number DYNDH1778, UDI/DI (EA) 10195327228477, UDI/DI (CS) 40195327228478; p) Model Number DYNDH1822, UDI/DI (EA) 10195327292294, UDI/DI (CS) 40195327292295; q) Model Number DYNDH1828, UDI/DI (EA) 10195327311308, UDI/DI (CS) 40195327311309; r) Model Number DYNJ0747885G, UDI/DI (EA) 10195327088729, UDI/DI (CS) 40195327088720; s) Model Number DYNJ34637G, UDI/DI (EA) 10193489368802, UDI/DI (CS) 40193489368803; t) Model Number DYNJ38616A, UDI/DI (EA) 10884389755952, UDI/DI (CS) 40884389755953; u) Model Number DYNJ42307A, UDI/DI (EA) 10888277298750, UDI/DI (CS) 40888277298751; v) Model Number DYNJ42752A, UDI/DI (EA) 10889942326099, UDI/DI (CS) 40889942326090; w) Model Number DYNJ43076, UDI/DI (EA) 10888277024533, UDI/DI (CS) 40888277024534; x) Model Number DYNJ43076A, UDI/DI (EA) 10195327080624, UDI/DI (CS) 40195327080625; y) Model Number DYNJ50485, UDI/DI (EA) 10888277992795, UDI/DI (CS) 40888277992796; z) Model Number DYNJ53658B, UDI/DI (EA) 10195327088705, UDI/DI (CS) 40195327088706; aa) Model Number DYNJ59752A, UDI/DI (EA) 10193489598575, UDI/DI (CS) 40193489598576; bb) Model Number DYNJ61992B, UDI/DI (EA) 10195327292652, UDI/DI (CS) 40195327292653; cc) Model Number DYNJ61992C, UDI/DI (EA) 10195327406592, UDI/DI (CS) 40195327406593; dd) Model Number DYNJ62690, UDI/DI (EA) 10193489682267, UDI/DI (CS) 40193489682268; ee) Model Number DYNJ63688A, UDI/DI (EA) 10193489326451, UDI/DI (CS) 40193489326452; ff) Model Number DYNJ63688B, UDI/DI (EA) 10193489405590, UDI/DI (CS) 40193489405591; gg) Model Number DYNJ63688C, UDI/DI (EA) 10193489432282, UDI/DI (CS) 40193489432283; hh) Model Number DYNJ63688G, UDI/DI (EA) 10193489897197, UDI/DI (CS) 40193489897198; ii) Model Number DYNJ63688I, UDI/DI (EA) 10195327037239, UDI/DI (CS) 40195327037230; jj) Model Number DYNJ83149, UDI/DI (EA) 10195327235710, UDI/DI (CS) 40195327235711; kk) Model Number P365500, UDI/DI (EA) 10889942141852, UDI/DI (CS) 40889942141853; ll) Model Number SPEC0168, UDI/DI (EA) 10884389869864, UDI/DI (CS) 40884389869865;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 18 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F

Z-2171-2023
Recall number
Z-2171-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
1130 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number OST011F, UDI/DI (EA) 10195327091347, UDI/DI (CS) 40195327091348

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 19 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTION, Model Number DYNJ63347A; e) TAVR FAIRFAX, Model Number DYNJ63634A; f) PARATHYROID PACK, Model Number DYNJ81389A; g) THYRIOD PACK, Model Number DYNJ83960; h) WMC COCHLEAR IMPLANT ADD ON, Model Number DYNJ907206D

Z-2172-2023
Recall number
Z-2172-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
1861 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS983069I, UDI/DI (EA) 10195327071868, UDI/DI (CS) 40195327071869; b) Model Number DYNJ30245, UDI/DI (EA) 10080196787692, UDI/DI (CS) 40080196787693; c) Model Number DYNJ47716B, UDI/DI (EA) 10193489454536, UDI/DI (CS) 40193489454537; d) Model Number DYNJ63347A, UDI/DI (EA) 10193489278064, UDI/DI (CS) 40193489278065; e) Model Number DYNJ63634A, UDI/DI (EA) 10195327143046, UDI/DI (CS) 40195327143047; f) Model Number DYNJ81389A, UDI/DI (EA) 10195327176785, UDI/DI (CS) 40195327176786; g) Model Number DYNJ83960, UDI/DI (EA) 10195327319991, UDI/DI (CS) 40195327319992; h) Model Number DYNJ907206D, UDI/DI (EA) 10195327307011, UDI/DI (CS) 40195327307012;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 20 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B

Z-2173-2023
Recall number
Z-2173-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
4148 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS840215O, UDI/DI (EA) 10193489448993, UDI/DI (CS) 40193489448994; b) Model Number DYNDH1187A, UDI/DI (EA) 10889942702633, UDI/DI (CS) 40889942702634; c) Model Number DYNJ906905B, UDI/DI (EA) 10193489884944, UDI/DI (CS) 40193489884945;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 21 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B

Z-2174-2023
Recall number
Z-2174-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ60126Bm UDI/DI (EA) 10195327118839, UDI/DI (CS) 40195327118830

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 22 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION KIT, Model Number ECVC1655; e) CVC INSERTION ACCESSORY KIT, Model Number ECVC7880; f) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635B

Z-2175-2023
Recall number
Z-2175-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
2739 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number CVI4880, UDI/DI (EA) 10195327233976, UDI/DI (CS) 40195327233977; Model Number CVI680C, UDI/DI (EA) 10653160992943, UDI/DI (CS) 40653160992944; Model Number DYNDC1786A, UDI/DI (EA) 10193489199116, UDI/DI (CS) 40193489199117; Model Number ECVC1655, UDI/DI (EA) 10653160254935, UDI/DI (CS) 40653160254936; Model Number ECVC7880, UDI/DI (EA) 10195327129613, UDI/DI (CS) 40195327129614; Model Number IVS3635B, UDI/DI (EA) 10653160992660, UDI/DI (CS) 40653160992661

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 23 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K

Z-2176-2023
Recall number
Z-2176-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
4644 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ46967F, UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048; b) Model Number DYNJ62557, UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153; c) Model Number DYNJ81973, UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878; d) Model Number TVS4000K, UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 24 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

Z-2177-2023
Recall number
Z-2177-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
4398 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1306, UDI/DI 10889942771523, UDI/DI 40889942771524; b) Model Number DYNDH1389B, UDI/DI 10193489449181, UDI/DI 40193489449182; c) Model Number DYNJ35262A, UDI/DI 10193489903430, UDI/DI 40193489903431; d) Model Number DYNJ39508A, UDI/DI 10889942628919, UDI/DI 40889942628910; e) Model Number DYNJ55954C, UDI/DI 10193489855791, UDI/DI 40193489855792; f) Model Number DYNJ63893, UDI/DI 10193489771565, UDI/DI 40193489771566; g) Model Number DYNJ63893A, UDI/DI 10195327316891, UDI/DI 40195327316892; h) Model Number DYNJ67367, UDI/DI 10193489895711, UDI/DI 40193489895712; i) Model Number DYNJ67381, UDI/DI 10193489896534, UDI/DI 40193489896535; j) Model Number DYNJ68321B, UDI/DI 10195327283346, UDI/DI 40195327283347; k) Model Number DYNJ82250, UDI/DI 10195327181758, UDI/DI 40195327181759; l) Model Number DYNJ84305, UDI/DI 10195327349813, UDI/DI 40195327349814; m) Model Number DYNJ904598B, UDI/DI 10889942946358, UDI/DI 40889942946359; n) Model Number DYNJ905002B, UDI/DI 10195327316860, UDI/DI 40195327316861; o) Model Number DYNJ905004B, UDI/DI 10193489782585, UDI/DI 40193489782586; p) Model Number DYNJ905004C, UDI/DI 10195327316938, UDI/DI 40195327316939; q) Model Number DYNJ908890, UDI/DI 10195327203399, UDI/DI 40195327203390; r) Model Number DYNJ908890A, UDI/DI 10195327259532, UDI/DI 40195327259533; s) Model Number DYNJ908892, UDI/DI 10195327204037, UDI/DI 40195327204038; t) Model Number DYNJ908892A, UDI/DI 10195327259556, UDI/DI 40195327259557;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 25 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A

Z-2178-2023
Recall number
Z-2178-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
2304 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ69864A, UDI/DI (EA) 10195327132057, UDI/DI (CS) 40195327132058

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 26 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F; e) CHP TRANSPLANT CDS, Model Number CDS983082J; f) CLOSURE CDS, Model Number CDS983704I; g) MIDLINE INSERTION TRAY, Model Number CVI4340; h) PORT INSERTION PACK, Model Number CVI4765; i) MAX BARRIER KIT, Model Number DYND2673B; j) POWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C; k) DEPIPPO PACK, Model Number DYNDA2011B; l) VEIN PROCEDURE KIT, Model Number DYNDA2076; m) SCLEROTHERAPY KIT, Model Number DYNDA2148A; n) IR SONO PACK, Model Number DYNDA2365B; o) ULTRASOUND BASIC KIT, Model Number DYNDC2099; p) PIV WITH ULTRASOUND KIT, Model Number DYNDC2399A; q) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; r) ULTRASOUND TRAY, Model Number DYNDH1204; s) PARA/THORACENTESIS TRAY, Model Number DYNDH1292; t) ULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319; u) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; v) PARA/THORACENTESIS TRAY, Model Number DYNDH1470C; w) US GUIDED LOC KIT, Model Number DYNDH1492; x) AMINO KIT, Model Number DYNDH1649; y) BREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A; z) ULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B; aa) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A; bb) CVL PACK, Model Number DYNJ00281N; cc) FEM POP PACK, Model Number DYNJ01964M; dd) MAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D; ee) VEIN PACK, Model Number DYNJ0309084D; ff) DR. BAHDOUCH PACK, Model Number DYNJ0351069; gg) ANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q; hh) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y; ii) JUDKINS PACK-LF, Model Number DYNJ0530948AR; jj) JUDKINS PACK-LF, Model Number DYNJ0586030P; kk) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q; ll) MINI PACK-LF, Model Number DYNJ0604540P; mm) MINI PACK-LF, Model Number DYNJ0604540Q; nn) BIOPSY PACK-LF, Model Number DYNJ0747885F; oo) PERC PACK-LF, Model Number DYNJ0774759O; pp) PERC PACK-LF, Model Number DYNJ0774759P; qq) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821N; rr) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821O; ss) CLOSURE PACK-LF, Model Number DYNJ0807503M; tt) LINE PLACEMENT PACK-LF, Model Number DYNJ0931376F; uu) DENTAL PACK-LF, Model Number DYNJ0952428; vv) VENOUS ACCESS TRAY, Model Number DYNJ20094K; ww) DEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D; xx) VEIN CLOSURE PACK, Model Number DYNJ32397B; yy) LARGE PROCEDURE PACK, Model Number DYNJ35524D; zz) RAD CVC TRAY, Model Number DYNJ35574A; aaa) WILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J; bbb) WILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G; ccc) STERILE PICC TRAY-LF, Model Number DYNJ36814B; ddd) PARA/THORA PACK, Model Number DYNJ37280C; eee) BASIC PACK, Model Number DYNJ37460A; fff) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F; ggg) MINOR PROCEDURE PACK, Model Number DYNJ38563O; hhh) VEIN PACK, Model Number DYNJ38682C; iii) ADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B; jjj) PICC LINE INSERTION, Model Number DYNJ39885A; kkk) PEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A; lll) HL VEIN STRIPPING PACK, Model Number DYNJ40374A; mmm) GENERAL USE PACK, Model Number DYNJ41137B; nnn) PICC LINE INSERTION WRO-LF, Model Number DYNJ41873B; ooo) CV ACCESS PACK WRO-LF, Model Number DYNJ41875B; ppp) RADIOLOGY PACK, Model Number DYNJ42172A; qqq) BASIC PACK, Model Number DYNJ42691; rrr) DRAINAGE TRAY, Model Number DYNJ42913; sss) DRAINAGE TRAY, Model Number DYNJ42913A; ttt) IR MINI KIT, Model Number DYNJ44519F; uuu) IR PERIPHERAL PACK, Model Number DYNJ45033A; vvv) EVLT CORE PACK, Model Number DYNJ45294; www) EVLT PACK, Model Number DYNJ45997C; xxx) PHLEBECTOMY PACK, Model Number DYNJ47502B; yyy) LINE KIT, Model Number DYNJ47987B; zzz) VEI

Z-2179-2023
Recall number
Z-2179-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ARTNC115, UDI/DI (EA) 10653160354338, UDI/DI (CS) 40653160354339; b) Model Number CDS980752I, UDI/DI (EA) 10889942428540, UDI/DI (CS) 40889942428541; c) Model Number CDS982858F, UDI/DI (EA) 10888277739215, UDI/DI (CS) 40888277739216; d) Model Number CDS982859F, UDI/DI (EA) 10888277739208, UDI/DI (CS) 40888277739209; e) Model Number CDS983082J, UDI/DI (EA) 10193489674514, UDI/DI (CS) 40193489674515; f) Model Number CDS983704I, UDI/DI (EA) 10193489854558, UDI/DI (CS) 40193489854559; g) Model Number CVI4340, UDI/DI (EA) 10653160309475, UDI/DI (CS) 40653160309476; h) Model Number CVI4765, UDI/DI (EA) 10193489953183, UDI/DI (CS) 40193489953184; i) Model Number DYND2673B, UDI/DI (EA) 10193489564358, UDI/DI (CS) 40193489564359; j) Model Number DYNDA1468C, UDI/DI (EA) 10889942843176, UDI/DI (CS) 40889942843177; k) Model Number DYNDA2011B, UDI/DI (EA) 10193489533026, UDI/DI (CS) 40193489533027; l) Model Number DYNDA2076, UDI/DI (EA) 10889942708505, UDI/DI (CS) 40889942708506; m) Model Number DYNDA2148A, UDI/DI (EA) 10888277734036, UDI/DI (CS) 40888277734037; n) Model Number DYNDA2365B, UDI/DI (EA) 10193489836448, UDI/DI (CS) 40193489836449; o) Model Number DYNDC2099, UDI/DI (EA) 10888277295674, UDI/DI (CS) 40888277295675; p) Model Number DYNDC2399A, UDI/DI (EA) 10889942446933, UDI/DI (CS) 40889942446934; q) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; r) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836; s) Model Number DYNDH1292, UDI/DI (EA) 10889942742233, UDI/DI (CS) 40889942742234; t) Model Number DYNDH1319, UDI/DI (EA) 10889942795475, UDI/DI (CS) 40889942795476; u) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 40193489111249; v) Model Number DYNDH1470C, UDI/DI (EA) 10195327297718, UDI/DI (CS) 40195327297719; w) Model Number DYNDH1492, UDI/DI (EA) 10193489434460, UDI/DI (CS) 40193489434461; x) Model Number DYNDH1649, UDI/DI (EA) 10193489944365, UDI/DI (CS) 40193489944366; y) Model Number DYNDL1596A, UDI/DI (EA) 10884389926505, UDI/DI (CS) 40884389926506; z) Model Number DYNDV2038B, UDI/DI (EA) 10193489919837, UDI/DI (CS) 40193489919838; aa) Model Number DYNDV2385A, UDI/DI (EA) 10195327298760, UDI/DI (CS) 40195327298761; bb) Model Number DYNJ00281N, UDI/DI (EA) 10193489449808, UDI/DI (CS) 40193489449809; cc) Model Number DYNJ01964M, UDI/DI (EA) 10193489648034, UDI/DI (CS) 40193489648035; dd) Model Number DYNJ0248546D, UDI/DI (EA) 10195327069285, UDI/DI (CS) 40195327069286; ee) Model Number DYNJ0309084D, UDI/DI (EA) 10889942885268, UDI/DI (CS) 40889942885269; ff) Model Number DYNJ0351069, UDI/DI (EA) 10889942059058, UDI/DI (CS) 40889942059059; gg) Model Number DYNJ0370436Q, UDI/DI (EA) 10888277779280, UDI/DI (CS) 40888277779281; hh) Model Number DYNJ0416535Y, UDI/DI (EA) 10193489994056, UDI/DI (CS) 40193489994057; ii) Model Number DYNJ0530948AR, UDI/DI (EA) 10195327141882, UDI/DI (CS) 40195327141883; jj) Model Number DYNJ0586030P, UDI/DI (EA) 10889942947140, UDI/DI (CS) 40889942947141; kk) Model Number DYNJ0604508Q, UDI/DI (EA) 10193489560190, UDI/DI (CS) 40193489560191; ll) Model Number DYNJ0604540P, UDI/DI (EA) 10193489560206, UDI/DI (CS) 40193489560207; mm) Model Number DYNJ0604540Q, UDI/DI (EA) 10193489839685, UDI/DI (CS) 40193489839686; nn) Model Number DYNJ0747885F, UDI/DI (EA) 10193489542318, UDI/DI (CS) 40193489542319; oo) Model Number DYNJ0774759O, UDI/DI (EA) 10195327091859, UDI/DI (CS) 40195327091850; pp) Model Number DYNJ0774759P, UDI/DI (EA) 10195327246136, UDI/DI (CS) 40195327246137; qq) Model Number DYNJ0785821N, UDI/DI (EA) 10193489915792, UDI/DI (CS) 40193489915793; rr) Model Number DYNJ0785821O, UDI/DI (EA) 10195327263737, UDI/DI (CS) 40195327263738; ss) Model Number DYNJ0807503M, UDI/DI (EA) 10889942091737, UDI/DI (CS) 40889942091738; tt) Model Number DYNJ0931376F, UDI/DI (EA) 10193489271508, UDI/DI (CS) 40193489271509; uu) Model Number DYNJ0952428, UDI/DI (EA) 10889942101610, UDI/DI (CS) 40889942101611; vv) Model Number DYNJ20094K, UDI/DI (EA) 10193489213256, UDI/DI (CS) 40193489213257; ww) Model Number DYNJ31934D, UDI/DI (EA) 10195327071509, UDI/DI (CS) 40195327071500; xx) Model Number DYNJ32397B, UDI/DI (EA) 10884389916650, UDI/DI (CS) 40884389916651; yy) Model Number DYNJ35524D, UDI/DI (EA) 10193489766103, UDI/DI (CS) 40193489766104; zz) Model Number DYNJ35574A, UDI/DI (EA) 10884389538067, UDI/DI (CS) 40884389538068; aaa) Model Number DYNJ35988J, UDI/DI (EA) 10195327024666, UDI/DI (CS) 40195327024667; bbb) Model Number DYNJ35989G, UDI/DI (EA) 10195327024673, UDI/DI (CS) 40195327024674; ccc) Model Number DYNJ36814B, UDI/DI (EA) 10195327075576, UDI/DI (CS) 40195327075577; ddd) Model Number DYNJ37280C, UDI/DI (EA) 10889942431656, UDI/DI (CS) 40889942431657; eee) Model Number DYNJ37460A, UDI/DI (EA) 10888277560437, UDI/DI (CS) 40888277560438; fff) Model Number DYNJ38326F, UDI/DI (EA) 10193489236675, UDI/DI (CS) 40193489236676; ggg) Model Number DYNJ38563O, UDI/DI (EA) 10193489251746, UDI/DI (CS) 40193489251747; hhh) Model Number DYNJ38682C, UDI/DI (EA) 10889942897193, UDI/DI (CS) 40889942897194; iii) Model Number DYNJ38714B, UDI/DI (EA) 10889942601936, UDI/DI (CS) 40889942601937; jjj) Model Number DYNJ39885A, UDI/DI (EA) 10889942539932, UDI/DI (CS) 40889942539933; kkk) Model Number DYNJ40306A, UDI/DI (EA) 10889942601929, UDI/DI (CS) 40889942601920; lll) Model Number DYNJ40374A, UDI/DI (EA) 10888277557949, UDI/DI (CS) 40888277557940; mmm) Model Number DYNJ41137B, UDI/DI (EA) 10889942260874, UDI/DI (CS) 40889942260875; nnn) Model Number DYNJ41873B, UDI/DI (EA) 10193489563061, UDI/DI (CS) 40193489563062; ooo) Model Number DYNJ41875B, UDI/DI (EA) 10193489563078, UDI/DI (CS) 40193489563079; ppp) Model Number DYNJ42172A, UDI/DI (EA) 10193489502718, UDI/DI (CS) 40193489502719; qqq) Model Number DYNJ42691, UDI/DI (EA) 10888277003507, UDI/DI (CS) 40888277003508; rrr) Model Number DYNJ42913, UDI/DI (EA) 10888277013209, UDI/DI (CS) 40888277013200; sss) Model Number DYNJ42913A, UDI/DI (EA) 10195327080600, UDI/DI (CS) 40195327080601; ttt) Model Number DYNJ44519F, UDI/DI (EA) 10193489467475, UDI/DI (CS) 40193489467476; uuu) Model Number DYNJ45033A, UDI/DI (EA) 10193489475807, UDI/DI (CS) 40193489475808; vvv) Model Number DYNJ45294, UDI/DI (EA) 10888277098978, UDI/DI (CS) 40888277098979; www) Model Number DYNJ45997C, UDI/DI (EA) 10889942684366, UDI/DI (CS) 40889942684367; xxx) Model Number DYNJ47502B, UDI/DI (EA) 10193489649222, UDI/DI (CS) 40193489649223; yyy) Model Number DYNJ47987B, UDI/DI (EA) 10193489867374, UDI/DI (CS) 40193489867375; zzz) Model Number DYNJ48454, UDI/DI (EA) 10888277595286, UDI/DI (CS) 40888277595287; aaaa) Model Number DYNJ48456B, UDI/DI (EA) 10889942733170, UDI/DI (CS) 40889942733171; bbbb) Model Number DYNJ49177F, UDI/DI (EA) 10888277774346, UDI/DI (CS) 40888277774347; cccc) Model Number DYNJ49737C, UDI/DI (EA) 10195327235888, UDI/DI (CS) 40195327235889; dddd) Model Number DYNJ51248B, UDI/DI (EA) 10889942873401, UDI/DI (CS) 40889942873402; eeee) Model Number DYNJ51340D, UDI/DI (EA) 10193489569810, UDI/DI (CS) 40193489569811; ffff) Model Number DYNJ51638C, UDI/DI (EA) 10195327039561, UDI/DI (CS) 40195327039562; gggg) Model Number DYNJ51705B, UDI/DI (EA) 10193489877175, UDI/DI (CS) 40193489877176; hhhh) Model Number DYNJ52122B, UDI/DI (EA) 10193489935301, UDI/DI (CS) 40193489935302; iiii) Model Number DYNJ52122C, UDI/DI (EA) 10195327260088, UDI/DI (CS) 40195327260089; jjjj) Model Number DYNJ52171, UDI/DI (EA) 10889942243471, UDI/DI (CS) 40889942243472; kkkk) Model Number DYNJ53122B, UDI/DI (EA) 10193489321227, UDI/DI (CS) 40193489321228; llll) Model Number DYNJ53135C, UDI/DI (EA) 10193489468434, UDI/DI (CS) 40193489468435; mmmm) Model Number DYNJ53319C, UDI/DI (EA) 10193489634495, UDI/DI (CS) 40193489634496; nnnn) Model Number DYNJ53435C, UDI/DI (EA) 10193489200867, UDI/DI (CS) 40193489200868; oooo) Model Number DYNJ53482A, UDI/DI (EA) 10889942917310, UDI/DI (CS) 40889942917311; pppp) Model Number DYNJ53658A, UDI/DI (EA) 10889942684403, UDI/DI (CS) 40889942684404; qqqq) Model Number DYNJ54131, UDI/DI (EA) 10889942466801, UDI/DI (CS) 40889942466802; rrrr) Model Number DYNJ54265, UDI/DI (EA) 10889942474004, UDI/DI (CS) 40889942474005; ssss) Model Number DYNJ54437C, UDI/DI (EA) 10193489243970, UDI/DI (CS) 40193489243971; tttt) Model Number DYNJ54569A, UDI/DI (EA) 10193489742954, UDI/DI (CS) 40193489742955; uuuu) Model Number DYNJ54894A, UDI/DI (EA) 10193489213553, UDI/DI (CS) 40193489213554; vvvv) Model Number DYNJ55063A, UDI/DI (EA) 10193489680546, UDI/DI (CS) 40193489680547; wwww) Model Number DYNJ55456, UDI/DI (EA) 10889942548446, UDI/DI (CS) 40889942548447; xxxx) Model Number DYNJ55457, UDI/DI (EA) 10889942548460, UDI/DI (CS) 40889942548461; yyyy) Model Number DYNJ55458, UDI/DI (EA) 10889942548453, UDI/DI (CS) 40889942548454; zzzz) Model Number DYNJ55723A, UDI/DI (EA) 10889942865536, UDI/DI (CS) 40889942865537

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 27 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B; j) RFA PACK, Model Number DYNJ57149; k) SPECIALS TRACE PACK, Model Number DYNJ57303B; l) CLOSURE PACK, Model Number DYNJ57514; m) EP PACK, Model Number DYNJ57594A; n) VEIN TRAY, Model Number DYNJ57736A; o) ENSEMBLE PICC LINE-LF, Model Number DYNJ57793; p) PICC LINE PACK-LF, Model Number DYNJ58160; q) ENDOVENOUS PACK, Model Number DYNJ58228; r) BIB AV FISTULA PACK, Model Number DYNJ58304; s) TRIPLE P KIT, Model Number DYNJ58424; t) LINQ TRAY, Model Number DYNJ58643A; u) TUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062; v) PICC PROCEDURE PACK, Model Number DYNJ59067; w) ENDOVASCULAR PACK, Model Number DYNJ59085; x) VEIN CLOSURE PACK, Model Number DYNJ59094; y) CLOSURE PROCEDURE, Model Number DYNJ59206; z) VNUS PACK, Model Number DYNJ59246; aa) DESERT CARDIOVASCULAR PACK, Model Number DYNJ59377; bb) EP LAB, Model Number DYNJ59392C; cc) VEIN PACK-LF, Model Number DYNJ59631; dd) PROCEDURE PACK, Model Number DYNJ59795A; ee) PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126A; ff) KF PACK, Model Number DYNJ60127A; gg) VENASEAL PACK, Model Number DYNJ60128A; hh) I.R. PACK, Model Number DYNJ60343A; ii) CLOSURE PACK, Model Number DYNJ60804; jj) CLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067; kk) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A; ll) ECMO PACK, Model Number DYNJ61243; mm) VEIN PACK, Model Number DYNJ61264; nn) UNIVERSAL PACK, Model Number DYNJ61433; oo) OCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517; pp) ENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295; qq) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295A; rr) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B; ss) SCLEROTHERAPY KIT, Model Number DYNJ62434A; tt) ABLATION PACK, Model Number DYNJ62540; uu) PROCEDURE PACK, Model Number DYNJ62588; vv) VEIN ABLATION, Model Number DYNJ63268B; ww) TF TAVR PACK, Model Number DYNJ63340; xx) AFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C; yy) ALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A; zz) NIR PACK, Model Number DYNJ63892; aaa) ABLATION PACK, Model Number DYNJ64068; bbb) LASER KIT, Model Number DYNJ64075A; ccc) EVLT, Model Number DYNJ64336; ddd) PROCEDURE PACK, Model Number DYNJ64372A; eee) PREMIER PROCEDURE PACK, Model Number DYNJ64393; fff) MINOR SET UP PACK, Model Number DYNJ64439; ggg) VIP PACK, Model Number DYNJ64666A; hhh) CT ABLATION PACK, Model Number DYNJ64928A; iii) ULTRASOUND KIT, Model Number DYNJ64930; jjj) VEIN CLOSURE PACK, Model Number DYNJ65189C; kkk) PACK,LTD BODY SSP, Model Number DYNJ65488B; lll) EVLT PACK, Model Number DYNJ65995; mmm) EVLT PACK, Model Number DYNJ65995A; nnn) EVLT PACK, Model Number DYNJ66005; ooo) JVL-PACK TUNNELED, Model Number DYNJ66065; ppp) EVLA PACK, Model Number DYNJ66258; qqq) EVLA PACK, Model Number DYNJ66258A; rrr) ANGIOGRAM SET UP PACK, Model Number DYNJ66260; sss) IR PACKER, Model Number DYNJ66620A; ttt) CLOSURE PROCEDURE PACK, Model Number DYNJ66741; uuu) PHYSIATRY PACK, Model Number DYNJ67414; vvv) FEM POP PACK, Model Number DYNJ67487A; www) SPECIALS PACK, Model Number DYNJ67504A; xxx) SPECIALS PACK, Model Number DYNJ67504B; yyy) RFA PACK, Model Number DYNJ67899; zzz) RR-BRACHY PACK, Model Number DYNJ68027; aaaa) COPS PROCEDURE PACK-LF, Model Number DYNJ68923A; bbbb) PROCEDURE PACK, Model Number DYNJ68968; cccc) PORT PACK, Model Number DYNJ68990; dddd) ACCESS PACK, Model Number DYNJ69017; eeee) KF PACK 2.0, Model Number DYNJ69619; ffff) NLK BASIC PACK, Model Number DYNJ69716A; gg

Z-2180-2023
Recall number
Z-2180-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ55841B, UDI/DI (EA) 10888277757684, UDI/DI (CS) 40888277757685; b) Model Number DYNJ55954B, UDI/DI (EA) 10193489214239, UDI/DI (CS) 40193489214230; c) Model Number DYNJ56140B, UDI/DI (EA) 10193489547672, UDI/DI (CS) 40193489547673; d) Model Number DYNJ56260B, UDI/DI (EA) 10193489569827, UDI/DI (CS) 40193489569828; e) Model Number DYNJ56392, UDI/DI (EA) 10889942640676, UDI/DI (CS) 40889942640677; f) Model Number DYNJ56392A, UDI/DI (EA) 10195327261405, UDI/DI (CS) 40195327261406; g) Model Number DYNJ56392B, UDI/DI (EA) 10195327323677, UDI/DI (CS) 40195327323678; h) Model Number DYNJ56507B, UDI/DI (EA) 10193489443479, UDI/DI (CS) 40193489443470; i) Model Number DYNJ56548B, UDI/DI (EA) 10193489813180, UDI/DI (CS) 40193489813181; j) Model Number DYNJ57149, UDI/DI (EA) 10889942721603, UDI/DI (CS) 40889942721604; k) Model Number DYNJ57303B, UDI/DI (EA) 10193489360646, UDI/DI (CS) 40193489360647; l) Model Number DYNJ57514, UDI/DI (EA) 10889942747849, UDI/DI (CS) 40889942747840; m) Model Number DYNJ57594A, UDI/DI (EA) 10889942963218, UDI/DI (CS) 40889942963219; n) Model Number DYNJ57736A, UDI/DI (EA) 10888277779709, UDI/DI (CS) 40888277779700; o) Model Number DYNJ57793, UDI/DI (EA) 10889942819164, UDI/DI (CS) 40889942819165; p) Model Number DYNJ58160, UDI/DI (EA) 10889942828647, UDI/DI (CS) 40889942828648; q) Model Number DYNJ58228, UDI/DI (EA) 10889942835492, UDI/DI (CS) 40889942835493; r) Model Number DYNJ58304, UDI/DI (EA) 10889942843732, UDI/DI (CS) 40889942843733; s) Model Number DYNJ58424, UDI/DI (EA) 10889942851836, UDI/DI (CS) 40889942851837; t) Model Number DYNJ58643A, UDI/DI (EA) 10193489809213, UDI/DI (CS) 40193489809214; u) Model Number DYNJ59062, UDI/DI (EA) 10889942941650, UDI/DI (CS) 40889942941651; v) Model Number DYNJ59067, UDI/DI (EA) 10889942930043, UDI/DI (CS) 40889942930044; w) Model Number DYNJ59085, UDI/DI (EA) 10889942932016, UDI/DI (CS) 40889942932017; x) Model Number DYNJ59094, UDI/DI (EA) 10889942933501, UDI/DI (CS) 40889942933502; y) Model Number DYNJ59206, UDI/DI (EA) 10888277765573, UDI/DI (CS) 40888277765574; z) Model Number DYNJ59246, UDI/DI (EA) 10888277767294, UDI/DI (CS) 40888277767295; aa) Model Number DYNJ59377, UDI/DI (EA) 10888277736290, UDI/DI (CS) 40888277736291; bb) Model Number DYNJ59392C, UDI/DI (EA) 10193489282245, UDI/DI (CS) 40193489282246; cc) Model Number DYNJ59631, UDI/DI (EA) 10888277764026, UDI/DI (CS) 40888277764027; dd) Model Number DYNJ59795A, UDI/DI (EA) 10193489566987, UDI/DI (CS) 40193489566988; ee) Model Number DYNJ60126A, UDI/DI (EA) 10193489247084, UDI/DI (CS) 40193489247085; ff) Model Number DYNJ60127A, UDI/DI (EA) 10193489729047, UDI/DI (CS) 40193489729048; gg) Model Number DYNJ60128A, UDI/DI (EA) 10193489544510, UDI/DI (CS) 40193489544511; hh) Model Number DYNJ60343A, UDI/DI (EA) 10193489573831, UDI/DI (CS) 40193489573832; ii) Model Number DYNJ60804, UDI/DI (EA) 10193489532784, UDI/DI (CS) 40193489532785; jj) Model Number DYNJ61067, UDI/DI (EA) 10193489542226, UDI/DI (CS) 40193489542227; kk) Model Number DYNJ61099A, UDI/DI (EA) 10193489463965, UDI/DI (CS) 40193489463966; ll) Model Number DYNJ61243, UDI/DI (EA) 10193489550917, UDI/DI (CS) 40193489550918; mm) Model Number DYNJ61264, UDI/DI (EA) 10193489554472, UDI/DI (CS) 40193489554473; nn) Model Number DYNJ61433, UDI/DI (EA) 10193489565171, UDI/DI (CS) 40193489565172; oo) Model Number DYNJ61517, UDI/DI (EA) 10193489577570, UDI/DI (CS) 40193489577571; pp) Model Number DYNJ62295, UDI/DI (EA) 10193489641165, UDI/DI (CS) 40193489641166; qq) Model Number DYNJ62295A, UDI/DI (EA) 10193489845952, UDI/DI (CS) 40193489845953; rr) Model Number DYNJ62295B, UDI/DI (EA) 10195327209933, UDI/DI (CS) 40195327209934; ss) Model Number DYNJ62434A, UDI/DI (EA) 10193489366273, UDI/DI (CS) 40193489366274; tt) Model Number DYNJ62540, UDI/DI (EA) 10193489666472, UDI/DI (CS) 40193489666473; uu) Model Number DYNJ62588, UDI/DI (EA) 10193489669831, UDI/DI (CS) 40193489669832; vv) Model Number DYNJ63268B, UDI/DI (EA) 10193489305111, UDI/DI (CS) 40193489305112; ww) Model Number DYNJ63340, UDI/DI (EA) 10193489741162, UDI/DI (CS) 40193489741163; xx) Model Number DYNJ63354C, UDI/DI (EA) 10195327273255, UDI/DI (CS) 40195327273256; yy) Model Number DYNJ63576A, UDI/DI (EA) 10193489429251, UDI/DI (CS) 40193489429252; zz) Model Number DYNJ63892, UDI/DI (EA) 10193489771435, UDI/DI (CS) 40193489771436; aaa) Model Number DYNJ64068, UDI/DI (EA) 10193489783131, UDI/DI (CS) 40193489783132; bbb) Model Number DYNJ64075A, UDI/DI (EA) 10193489231328, UDI/DI (CS) 40193489231329; ccc) Model Number DYNJ64336, UDI/DI (EA) 10193489801873, UDI/DI (CS) 40193489801874; ddd) Model Number DYNJ64372A, UDI/DI (EA) 10193489884685, UDI/DI (CS) 40193489884686; eee) Model Number DYNJ64393, UDI/DI (EA) 10193489809633, UDI/DI (CS) 40193489809634; fff) Model Number DYNJ64439, UDI/DI (EA) 10193489200485, UDI/DI (CS) 40193489200486; ggg) Model Number DYNJ64666A, UDI/DI (EA) 10193489317268, UDI/DI (CS) 40193489317269; hhh) Model Number DYNJ64928A, UDI/DI (EA) 10195327329815, UDI/DI (CS) 40195327329816; iii) Model Number DYNJ64930, UDI/DI (EA) 10193489231687, UDI/DI (CS) 40193489231688; jjj) Model Number DYNJ65189C, UDI/DI (EA) 10195327072001, UDI/DI (CS) 40195327072002; kkk) Model Number DYNJ65488B, UDI/DI (EA) 10193489443646, UDI/DI (CS) 40193489443647; lll) Model Number DYNJ65995, UDI/DI (EA) 10193489311549, UDI/DI (CS) 40193489311540; mmm) Model Number DYNJ65995A, UDI/DI (EA) 10195327068127, UDI/DI (CS) 40195327068128; nnn) Model Number DYNJ66005, UDI/DI (EA) 10193489312546, UDI/DI (CS) 40193489312547; ooo) Model Number DYNJ66065, UDI/DI (EA) 10193489319187, UDI/DI (CS) 40193489319188; ppp) Model Number DYNJ66258, UDI/DI (EA) 10193489325478, UDI/DI (CS) 40193489325479; qqq) Model Number DYNJ66258A, UDI/DI (EA) 10195327194239, UDI/DI (CS) 40195327194230; rrr) Model Number DYNJ66260, UDI/DI (EA) 10193489325461, UDI/DI (CS) 40193489325462; sss) Model Number DYNJ66620A, UDI/DI (EA) 10193489914245, UDI/DI (CS) 40193489914246; ttt) Model Number DYNJ66741, UDI/DI (EA) 10193489374940, UDI/DI (CS) 40193489374941; uuu) Model Number DYNJ67414, UDI/DI (EA) 10193489964646, UDI/DI (CS) 40193489964647; vvv) Model Number DYNJ67487A, UDI/DI (EA) 10193489888997, UDI/DI (CS) 40193489888998; www) Model Number DYNJ67504A, UDI/DI (EA) 10195327009618, UDI/DI (CS) 40195327009619; xxx) Model Number DYNJ67504B, UDI/DI (EA) 10195327331023, UDI/DI (CS) 40195327331024; yyy) Model Number DYNJ67899, UDI/DI (EA) 10193489454499, UDI/DI (CS) 40193489454490; zzz) Model Number DYNJ68027, UDI/DI (EA) 10193489469158, UDI/DI (CS) 40193489469159; aaaa) Model Number DYNJ68923A, UDI/DI (EA) 10195327070793, UDI/DI (CS) 40195327070794; bbbb) Model Number DYNJ68968, UDI/DI (EA) 10193489870398, UDI/DI (CS) 40193489870399; cccc) Model Number DYNJ68990, UDI/DI (EA) 10193489872613, UDI/DI (CS) 40193489872614; dddd) Model Number DYNJ69017, UDI/DI (EA) 10193489878158, UDI/DI (CS) 40193489878159; eeee) Model Number DYNJ69619, UDI/DI (EA) 10193489959444, UDI/DI (CS) 40193489959445; ffff) Model Number DYNJ69716A, UDI/DI (EA) 10195327250577, UDI/DI (CS) 40195327250578; gggg) Model Number DYNJ69820, UDI/DI (EA) 10193489981438, UDI/DI (CS) 40193489981439; hhhh) Model Number DYNJ80299, UDI/DI (EA) 10195327021931, UDI/DI (CS) 40195327021932; iiii) Model Number DYNJ81343, UDI/DI (EA) 10195327113063, UDI/DI (CS) 40195327113064; jjjj) Model Number DYNJ83152, UDI/DI (EA) 10195327237080, UDI/DI (CS) 40195327237081; kkkk) Model Number DYNJ83524, UDI/DI (EA) 10195327273491, UDI/DI (CS) 40195327273492; llll) Model Number DYNJ83931, UDI/DI (EA) 10195327315351, UDI/DI (CS) 40195327315352; mmmm) Model Number DYNJ83976, UDI/DI (EA) 10195327323196, UDI/DI (CS) 40195327323197; nnnn) Model Number DYNJ84172, UDI/DI (EA) 10195327338909, UDI/DI (CS) 40195327338900; oooo) Model Number DYNJ901348D, UDI/DI (EA) 10193489594683, UDI/DI (CS) 40193489594684; pppp) Model Number DYNJ901392D, UDI/DI (EA) 10193489539516, UDI/DI (CS) 40193489539517; qqqq) Model Number DYNJ902168D, UDI/DI (EA) 10193489866155, UDI/DI (CS) 40193489866156; rrrr) Model Number DYNJ902281, UDI/DI (EA) 10888277981416, UDI/DI (CS) 40888277981417; ssss) Model Number DYNJ905002A, UDI/DI (EA) 10889942911653, UDI/DI (CS) 40889942911654; tttt) Model Number DYNJ905335, UDI/DI (EA) 10889942875894, UDI/DI (CS) 40889942875895; uuuu) Model Number DYNJ905651B, UDI/DI (EA) 10193489925067, UDI/DI (CS) 40193489925068; vvvv) Model Number DYNJ905936B, UDI/DI (EA) 10193489422818, UDI/DI (CS) 40193489422819; wwww) Model Number DYNJ908752, UDI/DI (EA) 10195327171360, UDI/DI (CS) 40195327171361; xxxx) Model Number DYNJRA0585, UDI/DI (EA) 10888277580695, UDI/DI (CS) 40888277580696; yyyy) Model Number DYNJRA1155B, UDI/DI (EA) 10193489583717, UDI/DI (CS) 40193489583718; zzzz) Model Number DYNJRA1578, UDI/DI (EA) 10193489272789, UDI/DI (CS) 40193489272780;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 28 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK

Z-2181-2023
Recall number
Z-2181-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
# included in 3,740,814 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846; b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS) 40193489472814; c) Model Number IV8635D, UDI/DI (EA) 10653160990260, UDI/DI (CS) 40653160990261; d) Model Number IVS3300, UDI/DI (EA) 10653160307662, UDI/DI (CS) 40653160307663; e) Model Number IVS3485A, UDI/DI (EA) 10653160990154, UDI/DI (CS) 40653160990155; f) Model Number IVS3825, UDI/DI (EA) 10653160330752, UDI/DI (CS) 40653160330753; g) Model Number IVS3840A, UDI/DI (EA) 10193489476736, UDI/DI (CS) 40193489476737; h) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 40653160322130; i) Model Number MNS7695A, UDI/DI (EA) 10653160343455, UDI/DI (CS) 40653160343456; j) Model Number NG410A, UDI/DI (EA) 10889942945887, UDI/DI (CS) 40889942945888; k) Model Number PHS41739A, UDI/DI (EA) 10889942906802, UDI/DI (CS) 40889942906803; l) Model Number PHS479840M, UDI/DI (EA) 10193489682724, UDI/DI (CS) 40193489682725; m) Model Number SYNJ10303B, UDI/DI (EA) 10193489373745, UDI/DI (CS) 40193489373746; n) Model Number TVS4500A, UDI/DI (EA) 10816982023374, UDI/DI (CS) 40816982023375; o) Model Number TVS4500B, UDI/DI (EA) 10195327223564, UDI/DI (CS) 40195327223565; p) Model Number VC-PK, UDI/DI (EA) 10195327176891, UDI/DI (CS) 40195327176892;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 29 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A

Z-2182-2023
Recall number
Z-2182-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
1380 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4325, UDI/DI (EA) 10653160307037, UDI/DI (CS) 40653160307038; b) Model Number DT13351A, UDI/DI (EA) 10653160325581, UDI/DI (CS) 40653160325582

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 30 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871

Z-2183-2023
Recall number
Z-2183-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
35717 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDV2407A, UDI/DI (EA) 10193489817010UDI/DI (CS) 40193489817011; b) Model Number DYNDV2435, UDI/DI (EA) 10195327043667UDI/DI (CS) 40195327043668; c) Model Number DYNDV2518, UDI/DI (EA) 10195327089078UDI/DI (CS) 40195327089079; d) Model Number DYNJ64871, UDI/DI (EA) 10193489225365UDI/DI (CS) 40193489225366

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 31 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK, Model Number DYNJ67990; i) CLOSURE PACK, Model Number DYNJ83054A

Z-2184-2023
Recall number
Z-2184-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
11413 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDL1134A, UDI/DI (EA) 10080196994762, UDI/DI (CS)40080196994763; b) Model Number DYNDV2385, UDI/DI (EA) 10193489475593, UDI/DI (CS)40193489475594; c) Model Number DYNJ38885B, UDI/DI (EA) 10193489462333, UDI/DI (CS)40193489462334; d) Model Number DYNJ42902B, UDI/DI (EA) 10888277798007, UDI/DI (CS)40888277798008; e) Model Number DYNJ47215D, UDI/DI (EA) 10888277743021, UDI/DI (CS)40888277743022; f) Model Number DYNJ47717A, UDI/DI (EA) 10193489454529, UDI/DI (CS)40193489454520; g) Model Number DYNJ60586, UDI/DI (EA) 10193489528046, UDI/DI (CS)40193489528047; h) Model Number DYNJ67990, UDI/DI (EA) 10193489462531, UDI/DI (CS)40193489462532; i) Model Number DYNJ83054A, UDI/DI (EA) 10195327310516, UDI/DI (CS)40195327310517

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 32 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065

Z-2185-2023
Recall number
Z-2185-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
3975 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DT22065, UDI/DI (EA) 10653160326601, UDI/DI (CS) 40653160326602

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 33 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F; e) NEURO IR PACK, Model Number DYNJ35066I; f) NEURO IR PACK, Model Number DYNJ35066J; g) IR NEURO PACK, Model Number DYNJ39198L; h) IR NEURO PACK, Model Number DYNJ39198N; i) BASIC PACK, Model Number DYNJ39752A; j) C.I.C.N. ANGIO PACK, Model Number DYNJ53064B; k) ANGIOGRAPHIC PACK, Model Number DYNJ57442C; l) ANGIO/VENO PACK, Model Number DYNJ58346A; m) NEURO RADIOLOGY PACK, Model Number DYNJ59903A; n) NEURO RADIOLOGY PACK, Model Number DYNJ59903B; o) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112A; p) NEURO IR PACK, Model Number DYNJ60701D; q) RADIOLOGY NEURO DRAPE PAC, Model Number DYNJ61449; r) NEURO PACK, Model Number DYNJ61798D; s) BASIC CATH/ANGIO, Model Number DYNJ62591A; t) ANGIOGRAPHIC PACK, Model Number DYNJ64081A; u) ANGIO PACK, Model Number DYNJ64676; v) ANGIOGRAPHY PACK, Model Number DYNJ65963; w) NEURO PACK, Model Number DYNJ66241A; x) NEURO PACK, Model Number DYNJ66241B; y) NEURO PACK, Model Number DYNJ66241C; z) NEURO PACK, Model Number DYNJ66241D; aa) NEURO ACCESSORY PACK, Model Number DYNJ66790A; bb) NEURO ACCESSORY PACK, Model Number DYNJ66790B; cc) NEURO TRAY, Model Number DYNJ67075A; dd) NEURO PACK, Model Number DYNJ68956A; ee) NEURO PACK, Model Number DYNJ68956B; ff) NEURO CATH PACK, Model Number DYNJ69129; gg) NEURO CATH PACK, Model Number DYNJ83090; hh) ANGIO, Model Number DYNJ905151A; ii) KIT OR AORTOGRM ANGIOPLAST PHT, Model Number DYNJ906086A; jj) ARTHROGRAM TRAY, Model Number SPEC0232

Z-2186-2023
Recall number
Z-2186-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
14848 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ0429121G, UDI/DI (EA) 10193489711554, UDI/DI (CS) 40193489711555; b) Model Number DYNJ0878178J, UDI/DI (EA) 10193489914368, UDI/DI (CS) 40193489914369; c) Model Number DYNJ0878178K, UDI/DI (EA) 10195327328788, UDI/DI (CS) 40195327328789; d) Model Number DYNJ0948060F, UDI/DI (EA) 10889942825103, UDI/DI (CS) 40889942825104; e) Model Number DYNJ35066I, UDI/DI (EA) 10193489262292, UDI/DI (CS) 40193489262293; f) Model Number DYNJ35066J, UDI/DI (EA) 10195327091071, UDI/DI (CS) 40195327091072; g) Model Number DYNJ39198L, UDI/DI (EA) 10193489262919, UDI/DI (CS) 40193489262910; h) Model Number DYNJ39198N, UDI/DI (EA) 10195327102005, UDI/DI (CS) 40195327102006; i) Model Number DYNJ39752A, UDI/DI (EA) 10884389907238, UDI/DI (CS) 40884389907239; j) Model Number DYNJ53064B, UDI/DI (EA) 10193489789164, UDI/DI (CS) 40193489789165; k) Model Number DYNJ57442C, UDI/DI (EA) 10193489208535, UDI/DI (CS) 40193489208536; l) Model Number DYNJ58346A, UDI/DI (EA) 10193489774634, UDI/DI (CS) 40193489774635; m) Model Number DYNJ59903A, UDI/DI (EA) 10195327042868, UDI/DI (CS) 40195327042869; n) Model Number DYNJ59903B, UDI/DI (EA) 10195327131203, UDI/DI (CS) 40195327131204; o) Model Number DYNJ60112A, UDI/DI (EA) 10193489247039, UDI/DI (CS) 40193489247030; p) Model Number DYNJ60701D, UDI/DI (EA) 10195327383312, UDI/DI (CS) 40195327383313; q) Model Number DYNJ61449, UDI/DI (EA) 10193489567342, UDI/DI (CS) 40193489567343; r) Model Number DYNJ61798D, UDI/DI (EA) 10193489992632, UDI/DI (CS) 40193489992633; s) Model Number DYNJ62591A, UDI/DI (EA) 10193489793314, UDI/DI (CS) 40193489793315; t) Model Number DYNJ64081A, UDI/DI (EA) 10193489273748, UDI/DI (CS) 40193489273749; u) Model Number DYNJ64676, UDI/DI (EA) 10193489214383, UDI/DI (CS) 40193489214384; v) Model Number DYNJ65963, UDI/DI (EA) 10193489307702, UDI/DI (CS) 40193489307703; w) Model Number DYNJ66241A, UDI/DI (EA) 10193489938036, UDI/DI (CS) 40193489938037; x) Model Number DYNJ66241B, UDI/DI (EA) 10195327053482, UDI/DI (CS) 40195327053483; y) Model Number DYNJ66241C, UDI/DI (EA) 10195327096854, UDI/DI (CS) 40195327096855; z) Model Number DYNJ66241D, UDI/DI (EA) 10195327138370, UDI/DI (CS) 40195327138371; aa) Model Number DYNJ66790A, UDI/DI (EA) 10193489922479, UDI/DI (CS) 40193489922470; bb) Model Number DYNJ66790B, UDI/DI (EA) 10195327099268, UDI/DI (CS) 40195327099269; cc) Model Number DYNJ67075A, UDI/DI (EA) 10195327054533, UDI/DI (CS) 40195327054534; dd) Model Number DYNJ68956A, UDI/DI (EA) 10193489876291, UDI/DI (CS) 40193489876292; ee) Model Number DYNJ68956B, UDI/DI (EA) 10195327094348, UDI/DI (CS) 40195327094349; ff) Model Number DYNJ69129, UDI/DI (EA) 10193489892413, UDI/DI (CS) 40193489892414; gg) Model Number DYNJ83090, UDI/DI (EA) 10195327230937, UDI/DI (CS) 40195327230938; hh) Model Number DYNJ905151A, UDI/DI (EA) 10193489813418, UDI/DI (CS) 40193489813419; ii) Model Number DYNJ906086A, UDI/DI (EA) 10193489208689, UDI/DI (CS) 40193489208680; jj) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 34 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FETAL INTERVENTION, Model Number DYNJ66041A; f) FETAL INTERVENTION, Model Number DYNJ66041B

Z-2187-2023
Recall number
Z-2187-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
8974 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDV2200, UDI/DI (EA) 10888277742550, UDI/DI (CS) 40888277742551; b) Model Number DYNDV2397, UDI/DI (EA) 10193489388466, UDI/DI (CS) 40193489388467; c) Model Number DYNJ24276C, UDI/DI (EA) 10884389431184, UDI/DI (CS) 40884389431185; d) Model Number DYNJ66041, UDI/DI (EA) 10193489315820, UDI/DI (CS) 40193489315821; e) Model Number DYNJ66041A, UDI/DI (EA) 10193489480283, UDI/DI (CS) 40193489480284; f) Model Number DYNJ66041B, UDI/DI (EA) 10195327151072, UDI/DI (CS) 40195327151073;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 35 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N

Z-2188-2023
Recall number
Z-2188-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
78 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ902540N, UDI/DI (EA) 10193489916669, UDI/DI (CS) 40193489916660

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 36 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725

Z-2189-2023
Recall number
Z-2189-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
316 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS840214P, UDI/DI (EA) 10193489443196, UDI/DI (CS) 40193489443197; b) Model Number DYNJ82725, UDI/DI (EA) 10195327207380, UDI/DI (CS) 40195327207381

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 37 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A

Z-2190-2023
Recall number
Z-2190-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
540 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ58351A, UDI/DI (EA) 10888277739390, UDI/DI (CS) 40888277739391

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 38 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number DYNJ44322I; e) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D; f) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F; g) IR ARM PACK, Model Number DYNJ50712C; h) HYBRID PACK, Model Number DYNJ56907D; i) TUNNEL PACK, Model Number DYNJ58127B; j) CRANIOTOMY PACK, Model Number DYNJ61749A; k) CARPAL TUNNEL KIT, Model Number DYNJ63149A; l) ANGIOGRAPHY PACK, Model Number DYNJ65963A; m) ARTHROSCOPY PACK, Model Number DYNJ66402; n) ARTHROSCOPY PACK, Model Number DYNJ66402A; o) ARTHROSCOPY PACK, Model Number DYNJ66402C; p) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404; q) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404A; r) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404B; s) ARTHROSCOPY PACK, Model Number DYNJ68997; t) MURRIETA PACK, Model Number DYNJ69312; u) MURRIETA PACK, Model Number DYNJ69312A; v) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ82077; w) SCO ARTHROSCOPY, Model Number DYNJ906551A; x) US JOINT KIT, Model Number DYNJRA1944; y) HIP FRACTURE NERVE BLOCK, Model Number DYNJRA2085; z) ENS STERILE POUR IMPLANT-LF, Model Number OST011E; aa) ARTHROGRAM TRAY, Model Number PAIN1524C; bb) SHOULDER PACK-LF, Model Number PHS41748D; cc) LOWER EXTREMITY BLOCK PACK-RX, Model Number SPEC0204D; dd) UPPER EXTREMITY BLOCK PACK-RX, Model Number SPEC0205F;

Z-2191-2023
Recall number
Z-2191-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
19940 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS982889I, UDI/DI (EA) 10889942208067, UDI/DI (CS) 40889942208068; b) Model Number DYNDH1722, UDI/DI (EA) 10195327132163, UDI/DI (CS) 40195327132164; c) Model Number DYNJ0604434X, UDI/DI (EA) 10889942763801, UDI/DI (CS) 40889942763802; d) Model Number DYNJ44322I, UDI/DI (EA) 10193489530612, UDI/DI (CS) 40193489530613; e) Model Number DYNJ44348D, UDI/DI (EA) 10889942646722, UDI/DI (CS) 40889942646723; f) Model Number DYNJ44348F, UDI/DI (EA) 10193489530650, UDI/DI (CS) 40193489530651; g) Model Number DYNJ50712C, UDI/DI (EA) 10193489870169, UDI/DI (CS) 40193489870160; h) Model Number DYNJ56907D, UDI/DI (EA) 10193489831566, UDI/DI (CS) 40193489831567; i) Model Number DYNJ58127B, UDI/DI (EA) 10193489482799, UDI/DI (CS) 40193489482790; j) Model Number DYNJ61749A, UDI/DI (EA) 10195327063016, UDI/DI (CS) 40195327063017; k) Model Number DYNJ63149A, UDI/DI (EA) 10193489786477, UDI/DI (CS) 40193489786478; l) Model Number DYNJ65963A, UDI/DI (EA) 10193489992052, UDI/DI (CS) 40193489992053; m) Model Number DYNJ66402, UDI/DI (EA) 10193489352016, UDI/DI (CS) 40193489352017; n) Model Number DYNJ66402A, UDI/DI (EA) 10193489840520, UDI/DI (CS) 40193489840521; o) Model Number DYNJ66402C, UDI/DI (EA) 10193489938456, UDI/DI (CS) 40193489938457; p) Model Number DYNJ66404, UDI/DI (EA) 10193489352078, UDI/DI (CS) 40193489352079; q) Model Number DYNJ66404A, UDI/DI (EA) 10193489840537, UDI/DI (CS) 40193489840538; r) Model Number DYNJ66404B, UDI/DI (EA) 10193489941166, UDI/DI (CS) 40193489941167; s) Model Number DYNJ68997, UDI/DI (EA) 10193489874655, UDI/DI (CS) 40193489874656; t) Model Number DYNJ69312, UDI/DI (EA) 10193489929461, UDI/DI (CS) 40193489929462; u) Model Number DYNJ69312A, UDI/DI (EA) 10195327216771, UDI/DI (CS) 40195327216772; v) Model Number DYNJ82077, UDI/DI (EA) 10195327166953, UDI/DI (CS) 40195327166954; w) Model Number DYNJ906551A, UDI/DI (EA) 10195327124083, UDI/DI (CS) 40195327124084; x) Model Number DYNJRA1944, UDI/DI (EA) 10195327133047, UDI/DI (CS) 40195327133048; y) Model Number DYNJRA2085, UDI/DI (EA) 10195327286743, UDI/DI (CS) 40195327286744; z) Model Number OST011E, UDI/DI (EA) 10888277589322, UDI/DI (CS) 40888277589323; aa) Model Number PAIN1524C, UDI/DI (EA) 10195327271602, UDI/DI (CS) 40195327271603; bb) Model Number PHS41748D, UDI/DI (EA) 10193489784794, UDI/DI (CS) 40193489784795; cc) Model Number SPEC0204D, UDI/DI (EA) 10193489302981, UDI/DI (CS) 40193489302982; dd) Model Number SPEC0205F, UDI/DI (EA) 10193489212884, UDI/DI (CS) 40193489212885

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 39 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G

Z-2192-2023
Recall number
Z-2192-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ44322G, UDI/DI (EA) 10889942646661, UDI/DI (CS) 40889942646662

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 40 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION KIT, Model Number ART775B; e) ARTERIAL LINE KIT W/O CATHETER, Model Number ART890A; f) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; g) ARTERIAL LINE START KIT W/O CATH, Model Number P42453;

Z-2193-2023
Recall number
Z-2193-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
2590 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number ART1070A, UDI/DI EA 10653160358329, UDI/DI CS 00653160358322; b) Model Number ART1160, UDI/DI EA 10653160355762, UDI/DI CS 00653160355765; c) Model Number ART1180, UDI/DI EA 10653160355472, UDI/DI CS 00653160355475; d) Model Number ART775B, UDI/DI EA 10653160353560, UDI/DI CS 00653160353563; e) Model Number ART890A, UDI/DI EA 10653160356677, UDI/DI CS 00653160356670; f) Model Number ART995, UDI/DI EA 10193489190502, UDI/DI CS 20193489190509; g) Model Number P42453, UDI/DI EA 10653160323792, UDI/DI CS 00653160323795

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 41 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A; d) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A; e) CENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725; f) INTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915; g) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B; h) CVC BUNDLE KIT 20CM, Model Number ECVC2001; i) 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A; j) CVC BUNDLE KIT 16CM, Model Number ECVC2240A; k) FIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320; l) 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B; m) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555; n) 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560; o) FIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720; p) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745; q) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750; r) 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770; s) CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895; t) SHEATH INTRODUCER BUNDLE, Model Number ECVC2930; u) DUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940; v) TRIPLE LUMEN BUNDLE, Model Number ECVC2965; w) TRIPLE LUMEN BUNDLE, Model Number ECVC3155; x) CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A; y) CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286; z) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355; aa) TRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395; bb) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460; cc) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505; dd) 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545; ee) TRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A; ff) CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A; gg) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785; hh) MULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900; ii) QUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135; jj) AVA HIGH FLOW BUNDLE, Model Number ECVC4300; kk) 20CM 7F CVC INSERTION TRAY, Model Number ECVC4335; ll) OLEAN GENERAL CVC BUNDLE, Model Number ECVC4615; mm) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A; nn) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A; oo) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880; pp) DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985; qq) QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995; rr) 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A; ss) TRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015; tt) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020; uu) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A; vv) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080; ww) 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B; xx) TRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200; yy) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270; zz) CVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310; aaa) CVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315; bbb) TRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B; ccc) CVC ZONE DEFENSE BUNDLE, Model Number ECVC5385; ddd) TRIPLE LUMEN BUNDLE, Model Number ECVC5475; eee) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number ECVC5480; fff) CVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A; ggg) CNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A; hhh) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A; iii) CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A; jjj) CVC DOUBLE LUMEN 16CM, Model Number ECVC5585B; kkk) CVC TRIPLE LUMEN 16CM, Model Number ECVC5590B; lll) PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;

Z-2194-2023
Recall number
Z-2194-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
10080 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model number ECVC1320: UDI/DI (EA) 10653160335795, UDI/DI (CS) 00653160335798; b) Model number ECVC1345A: UDI/DI (EA) 10653160334606, UDI/DI (CS) 00653160334609; c) Model number ECVC1490A: UDI/DI (EA) 10653160359036, UDI/DI (CS) 00653160359039; d) Model number ECVC1495A: UDI/DI (EA) 10653160358794, UDI/DI (CS) 00653160358797; e) Model number ECVC1725: UDI/DI (EA) 10653160334507, UDI/DI (CS) 00653160334500; f) Model number ECVC1915: UDI/DI (EA) 10653160334446, UDI/DI (CS) 00653160334449; g) Model number ECVC1970B: UDI/DI (EA) 10653160357155, UDI/DI (CS) 00653160357158; h) Model number ECVC2001: UDI/DI (EA) 10653160334415, UDI/DI (CS) 00653160334418; i) Model number ECVC2205A: UDI/DI (EA) 10653160357148, UDI/DI (CS) 00653160357141; j) Model number ECVC2240A: UDI/DI (EA) 10653160334361, UDI/DI (CS) 00653160334364; k) Model number ECVC2320: UDI/DI (EA) 10653160332480, UDI/DI (CS) 00653160332483; l) Model number ECVC2440B: UDI/DI (EA) 10653160358930, UDI/DI (CS) 00653160358933; m) Model number ECVC2555: UDI/DI (EA) 10653160336570, UDI/DI (CS) 00653160336573; n) Model number ECVC2560: UDI/DI (EA) 10653160334286, UDI/DI (CS) 00653160334289; o) Model number ECVC2720: UDI/DI (EA) 10653160332657, UDI/DI (CS) 00653160332650; p) Model number ECVC2745: UDI/DI (EA) 10653160334224, UDI/DI (CS) 00653160334227; q) Model number ECVC2750: UDI/DI (EA) 10653160334217, UDI/DI (CS) 00653160334210; r) Model number ECVC2770: UDI/DI (EA) 10653160332671, UDI/DI (CS) 00653160332674; s) Model number ECVC2895: UDI/DI (EA) 10653160332725, UDI/DI (CS) 00653160332728; t) Model number ECVC2930: UDI/DI (EA) 10653160335368, UDI/DI (CS) 00653160335361; u) Model number ECVC2940: UDI/DI (EA) 10653160335351, UDI/DI (CS) 00653160335354; v) Model number ECVC2965: UDI/DI (EA) 10653160338611, UDI/DI (CS) 00653160338614; w) Model number ECVC3155: UDI/DI (EA) 10653160334132, UDI/DI (CS) 00653160334135; x) Model number ECVC3285A: UDI/DI (EA) 10653160358572, UDI/DI (CS) 00653160358575; y) Model number ECVC3286: UDI/DI (EA) 10653160358398, UDI/DI (CS) 00653160358391; z) Model number ECVC3355: UDI/DI (EA) 10653160333982, UDI/DI (CS) 00653160333985; aa) Model number ECVC3395: UDI/DI (EA) 10653160338635, UDI/DI (CS) 00653160338638; bb) Model number ECVC3460: UDI/DI (EA) 10653160332794, UDI/DI (CS) 00653160332797; cc) Model number ECVC3505: UDI/DI (EA) 10653160334767, UDI/DI (CS) 00653160334760; dd) Model number ECVC3545: UDI/DI (EA) 10653160334774, UDI/DI (CS) 00653160334777; ee) Model number ECVC3735A: UDI/DI (EA) 10653160334798, UDI/DI (CS) 00653160334791; ff) Model number ECVC3755A: UDI/DI (EA) 10653160334804, UDI/DI (CS) 00653160334807; gg) Model number ECVC3785: UDI/DI (EA) 10653160336006, UDI/DI (CS) 00653160336009; hh) Model number ECVC3900: UDI/DI (EA) 10653160334828, UDI/DI (CS) 00653160334821; ii) Model number ECVC4135: UDI/DI (EA) 10653160335900, UDI/DI (CS) 00653160335903; jj) Model number ECVC4300: UDI/DI (EA) 10653160334873, UDI/DI (CS) 00653160334876; kk) Model number ECVC4335: UDI/DI (EA) 10653160357285, UDI/DI (CS) 00653160357288; ll) Model number ECVC4615: UDI/DI (EA) 10653160336075, UDI/DI (CS) 00653160336078; mm) Model number ECVC4635A: UDI/DI (EA) 10653160352112, UDI/DI (CS) 00653160352115; nn) Model number ECVC4640A: UDI/DI (EA) 10653160352105, UDI/DI (CS) 00653160352108; oo) Model number ECVC4880: UDI/DI (EA) 10653160333111, UDI/DI (CS) 00653160333114; pp) Model number ECVC4985: UDI/DI (EA) 10653160335269, UDI/DI (CS) 00653160335262; qq) Model number ECVC4995: UDI/DI (EA) 10653160335283, UDI/DI (CS) 00653160335286; rr) Model number ECVC5010A: UDI/DI (EA) 10653160335290, UDI/DI (CS) 00653160335293; ss) Model number ECVC5015: UDI/DI (EA) 10653160338956, UDI/DI (CS) 00653160338959; tt) Model number ECVC5020: UDI/DI (EA) 10653160334903, UDI/DI (CS) 00653160334906; uu) Model number ECVC5020A: UDI/DI (EA) 10653160358251, UDI/DI (CS) 00653160358254; vv) Model number ECVC5080: UDI/DI (EA) 10653160337690, UDI/DI (CS) 00653160337693; ww) Model number ECVC5135B: UDI/DI (EA) 10653160353652, UDI/DI (CS) 00653160353655; xx) Model number ECVC5200: UDI/DI (EA) 10653160336150, UDI/DI (CS) 00653160336153; yy) Model number ECVC5270: UDI/DI (EA) 10653160336198, UDI/DI (CS) 00653160336191; zz) Model number ECVC5310: UDI/DI (EA) 10653160336211, UDI/DI (CS) 00653160336214; aaa) Model number ECVC5315: UDI/DI (EA) 10653160339465, UDI/DI (CS) 00653160339468; bbb) Model number ECVC5355B: UDI/DI (EA) 10653160357742, UDI/DI (CS) 00653160357745; ccc) Model number ECVC5385: UDI/DI (EA) 10653160336518, UDI/DI (CS) 00653160336511; ddd) Model number ECVC5475: UDI/DI (EA) 10653160338116, UDI/DI (CS) 00653160338119; eee) Model number ECVC5480: UDI/DI (EA) 10653160339458, UDI/DI (CS) 00653160339451; fff) Model number ECVC5525A: UDI/DI (EA) 10653160338130, UDI/DI (CS) 00653160338133; ggg) Model number ECVC5530A: UDI/DI (EA) 10653160345596, UDI/DI (CS) 00653160345599; hhh) Model number ECVC5540A: UDI/DI (EA) 10653160335009, UDI/DI (CS) 00653160335002; iii) Model number ECVC5560A: UDI/DI (EA) 10653160336501, UDI/DI (CS) 00653160336504; jjj) Model number ECVC5585B: UDI/DI (EA) 10653160357711, UDI/DI (CS) 00653160357714; kkk) Model number ECVC5590B: UDI/DI (EA) 10653160357728, UDI/DI (CS) 00653160357721; lll) Model number ECVC5650: UDI/DI (EA) 10653160336457, UDI/DI (CS) 00653160336450; mmm) Model number ECVC5655: UDI/DI (EA) 10653160337621, UDI/DI (CS) 00653160337624; nnn) Model number ECVC5660: UDI/DI (EA) 10653160337638, UDI/DI (CS) 00653160337631; ooo) Model number ECVC5665: UDI/DI (EA) 10653160341505, UDI/DI (CS) 00653160341508; ppp) Model number ECVC5810: UDI/DI (EA) 10653160336419, UDI/DI (CS) 00653160336412; qqq) Model number ECVC5815: UDI/DI (EA) 10653160336402, UDI/DI (CS) 00653160336405; rrr) Model number ECVC5855B: UDI/DI (EA) 10653160355113, UDI/DI (CS) 00653160355116; sss) Model number ECVC5870A: UDI/DI (EA) 10653160338383, UDI/DI (CS) 00653160338386; ttt) Model number ECVC5985B: UDI/DI (EA) 10653160357797, UDI/DI (CS) 00653160357790; uuu) Model number ECVC6015B: UDI/DI (EA) 10653160357704, UDI/DI (CS) 00653160357707; vvv) Model number ECVC6070: UDI/DI (EA) 10653160335863, UDI/DI (CS) 00653160335866; www) Model number ECVC6075: UDI/DI (EA) 10653160338437, UDI/DI (CS) 00653160338430; xxx) Model number ECVC6120: UDI/DI (EA) 10653160336532, UDI/DI (CS) 00653160336535; yyy) Model number ECVC6255: UDI/DI (EA) 10653160336525, UDI/DI (CS) 00653160336528; zzz) Model number ECVC6260: UDI/DI (EA) 10653160336488, UDI/DI (CS) 00653160336481; aaaa) Model number ECVC6265: UDI/DI (EA) 10653160342922, UDI/DI (CS) 00653160342925; bbbb) Model number ECVC6340A: UDI/DI (EA) 10653160355038, UDI/DI (CS) 00653160355031; cccc) Model number ECVC6355: UDI/DI (EA) 10653160336396, UDI/DI (CS) 00653160336399; dddd) Model number ECVC6370: UDI/DI (EA) 10653160333425, UDI/DI (CS) 00653160333428; eeee) Model number ECVC6490A: UDI/DI (EA) 10653160344360, UDI/DI (CS) 00653160344363; ffff) Model number ECVC6505: UDI/DI (EA) 10653160336327, UDI/DI (CS) 00653160336320; gggg) Model number ECVC6540: UDI/DI (EA) 10653160339397, UDI/DI (CS) 00653160339390; hhhh) Model number ECVC6550: UDI/DI (EA) 10653160335276, UDI/DI (CS) 00653160335279; iiii) Model number ECVC6555: UDI/DI (EA) 10653160336341, UDI/DI (CS) 00653160336344; jjjj) Model number ECVC6585A: UDI/DI (EA) 10653160338826, UDI/DI (CS) 00653160338829; kkkk) Model number ECVC6595: UDI/DI (EA) 10653160337485, UDI/DI (CS) 00653160337488; llll) Model number ECVC6655A: UDI/DI (EA) 10653160339267, UDI/DI (CS) 00653160339260; mmmm) Model number ECVC6680A: UDI/DI (EA) 10653160337164, UDI/DI (CS) 00653160337167; nnnn) Model number ECVC6690: UDI/DI (EA) 10653160336600, UDI/DI (CS) 00653160336603; oooo) Model number ECVC6765: UDI/DI (EA) 10653160336839, UDI/DI (CS) 00653160336832; pppp) Model number ECVC6800: UDI/DI (EA) 10653160335092, UDI/DI (CS) 00653160335095; qqqq) Model number ECVC6800A: UDI/DI (EA) 10653160355694, UDI/DI (CS) 00653160355697; rrrr) Model number ECVC6815: UDI/DI (EA) 10653160335115, UDI/DI (CS) 00653160335118; ssss) Model number ECVC6825A: UDI/DI (EA) 10653160336631, UDI/DI (CS) 00653160336634; tttt) Model number ECVC6835: UDI/DI (EA) 10653160336778, UDI/DI (CS) 00653160336771; uuuu) Model number ECVC6840: UDI/DI (EA) 10653160336761, UDI/DI (CS) 00653160336764; vvvv) Model number ECVC6845: UDI/DI (EA) 10653160339366, UDI/DI (CS) 00653160339369; wwww) Model number ECVC6850: UDI/DI (EA) 10653160338819, UDI/DI (CS) 00653160338812; xxxx) Model number ECVC6915: UDI/DI (EA) 10653160336723, UDI/DI (CS) 00653160336726; yyyy) Model number ECVC6920: UDI/DI (EA) 10653160336716, UDI/DI (CS) 00653160336719; zzzz) Model number ECVC6970: UDI/DI (EA) 10653160336693, UDI/DI (CS) 00653160336696

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 42 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;

Z-2195-2023
Recall number
Z-2195-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
620 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4510, UDI/DI (EA) 10653160321194, UDI/DI (CS) 00653160321197; b) Model Number STCVC01145B, UDI/DI (EA) 10653160351924, UDI/DI (CS) 00653160351927; c) Model Number STCVC2000, UDI/DI (EA) 10653160336792, UDI/DI (CS) 00653160336795

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 43 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;

Z-2196-2023
Recall number
Z-2196-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
2420 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ44410G. UDI/DI (EA)10193489958447, UDI/DI (CS)40193489958448; b) Model Number DYNJ9048708I. UDI/DI (EA)10195327072735, UDI/DI (CS)40195327072736; c) Model Number PHS762887001B. UDI/DI (EA)10889942849314, UDI/DI (CS) 40889942849315; d) Model Number TVS4700. UDI/DI (EA)10816982023398, UDI/DI (CS)40816982023399;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 44 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A

Z-2197-2023
Recall number
Z-2197-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number MNS10750A, UDI/DI (EA) 10653160356073, UDI/DI (CS) 00653160356076

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 45 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;

Z-2198-2023
Recall number
Z-2198-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
575 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1112, UDI/DI (EA) 10889942277360, UDI/DI (CS) 40889942277361; b) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; c) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 46 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245A; e) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245B; f) ARTERIAL LINE BUNDLE, Model Number ART255; g) ARTERIAL LINE BUNDLE, Model Number ART560; h) A LINE TRAY, Model Number ART690; i) ARTERIAL LINE TRAY, Model Number ART840; j) 18GX6" FEMORAL ART LINE KIT, Model Number ART960; k) 20Gx3" RADIAL ART LINE KIT, Model Number ART970; l) BIOPSY/ASPIRATION TRAY, Model Number BT235A; m) PERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825; n) PICC INSERTION KIT, Model Number CVI3735; o) PICC INSERTION BUNDLE, Model Number CVI4025A; p) VASCULAR ACCESS INSERTION KIT, Model Number CVI4180; q) VASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265; r) UNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430; s) PEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A; t) CVC ACCESSORY BUNDLE, Model Number CVI4505; u) DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655; v) FISHLINE KIT, Model Number CVI4725; w) VENOUS ACCESS TRAY, Model Number CVI4830A; x) VENOUS ACCESS TRAY, Model Number CVI4830B; y) CVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905; z) MVHS CVC LUMEN TRAY, Model Number CVI4920; aa) ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A; bb) ADULT VASCULAR ACCESS BUNDLE, Model Number DT22860; cc) TOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A; dd) MAX BARRIER KIT, Model Number DYND2673B; ee) THYROID FNA TRAY, Model Number DYNDA2238A; ff) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; gg) BASIC BIOPSY TRAY, Model Number DYNDH1534; hh) ULTRASOUND BIOPSY, Model Number DYNDH1542; ii) BIOPSY TRAY, Model Number DYNDH1661; jj) USG PIV KIT, Model Number DYNDV2536A; kk) ULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B; ll) PORT INSERTION KIT, Model Number MNS11590; mm) RADIOLOGY TRAY, Model Number MNS11625; nn) BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065; oo) INTRA PROBE COVER 5X96 KIT, Model Number P155598; pp) ULTRASOUND PROBE KIT, Model Number P482986; qq) ARTHROGRAM TRAY, Model Number SPEC0232; rr) ULTRA CORE BIOPSY KIT, Model Number SPEC0291B;

Z-2199-2023
Recall number
Z-2199-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
39391 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239; b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683; c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028; d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011; e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445; f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990; g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825; h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012; i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927; j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912; k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929; l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912; m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981; n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547; o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059; p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454; q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261; r) Model Number CVI4430, UDI/DI (EA) 10653160314370, UDI/DI (CS) 00653160314373; s) Model Number CVI4450A, UDI/DI (EA) 10653160320517, UDI/DI (CS) 00653160320510; t) Model Number CVI4505, UDI/DI (EA) 10653160319047, UDI/DI (CS) 00653160319040; u) Model Number CVI4655, UDI/DI (EA) 10193489190373, UDI/DI (CS) 20193489190370; v) Model Number CVI4725, UDI/DI (EA) 10193489199871, UDI/DI (CS) 20193489199878; w) Model Number CVI4830A, UDI/DI (EA) 10653160353553, UDI/DI (CS) 00653160353556; x) Model Number CVI4830B, UDI/DI (EA) 10653160358534, UDI/DI (CS) 00653160358537; y) Model Number CVI4905, UDI/DI (EA) 10653160355618, UDI/DI (CS) 00653160355611; z) Model Number CVI4920, UDI/DI (EA) 10653160355847, UDI/DI (CS) 00653160355840; aa) Model Number DT22570A, UDI/DI (EA) 10653160346074, UDI/DI (CS) 00653160346077; bb) Model Number DT22860, UDI/DI (EA) 10653160359142, UDI/DI (CS) 00653160359145; cc) Model Number DYKM1790A, UDI/DI (EA) 10193489112412, UDI/DI (CS) 20193489112419; dd) Model Number DYND2673B, UDI/DI (EA) 10193489191394, UDI/DI (CS) 20193489191391; ee) Model Number DYNDA2238A, UDI/DI (EA) 10193489191554, UDI/DI (CS) 20193489191551; ff) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 20193489111245; gg) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 20193489197089; hh) Model Number DYNDH1542, UDI/DI (EA) 10193489197396, UDI/DI (CS) 20193489197393; ii) Model Number DYNDH1661, UDI/DI (EA) 10193489111521, UDI/DI (CS) 20193489111528; jj) Model Number DYNDV2536A, UDI/DI (EA) 10653160357872, UDI/DI (CS) 00653160357875; kk) Model Number DYNJ0182378B, UDI/DI (EA) 10653160338536, UDI/DI (CS) 00653160338539; ll) Model Number MNS11590, UDI/DI (EA) 10653160321293, UDI/DI (CS) 00653160321296; mm) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 00653160322132; nn) Model Number MNS12065, UDI/DI (EA) 10653160331193, UDI/DI (CS) 00653160331196; oo) Model Number P155598, UDI/DI (EA) 10888277902237, UDI/DI (CS) 40888277902238; pp) Model Number P482986, UDI/DI (EA) 10888277903630, UDI/DI (CS) 40888277903631; qq) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419; rr) Model Number SPEC0291B, UDI/DI (EA) 10889942453054, UDI/DI (CS) 40889942453055;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 47 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI KIT , Model Number BSIPIV1010; e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011; f) PICC INSERTION TRAY , Model Number CVI3805; g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B; h) CENTRAL LINE INSERTION TRAY , Model Number DT19810; i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A; j) USG PIV KIT , Model Number DYNDV2536; k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547; l) USG PIV KIT , Model Number DYNDV2567; m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A; n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB; o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB; p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB; q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB; r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B; s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C; t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770; u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A; v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A; w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B; x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005; y) MIDLINE KIT 4F SL MB , Model Number MID0001; z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003; aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005; bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A; cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010; dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011; ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012; ff) PICC BUNDLE 5FR DL , Model Number PICC0013; gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A; hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;

Z-2200-2023
Recall number
Z-2200-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
70648 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892; b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864; c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939; d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526; e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310; f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088; g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421; h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659; i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983; j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679; k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249; l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458; m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542; n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805; o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823; p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412; q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429; r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060; s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957; t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233; u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777; v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667; w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338; x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145; y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628; z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337; aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184; bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238; cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115; dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845; ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494; ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811; gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555; hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 48 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219

Z-2201-2023
Recall number
Z-2201-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
51200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNDA1219, UDI/DI (EA) 10888277283879, UDI/DI (CS) 40888277283870

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 49 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464;

Z-2202-2023
Recall number
Z-2202-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
572 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4770A, UDI/DI (EA) 10653160350828, UDI/DI (CS) 00653160350821; b) Model Number DT21275, UDI/DI (EA) 10653160318934, UDI/DI (CS) 00653160318937; c) Model Number EBSI1382, UDI/DI (EA) 10193489196269, UDI/DI (CS) 20193489196266; d) Model Number EBSI1464, UDI/DI (EA) 10193489198959, UDI/DI (CS) 20193489198956;

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 50 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C

Z-2203-2023
Recall number
Z-2203-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
1240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number SPEC0130C, UDI/DI (EA) 10193489196641, UDI/DI (CS) 20193489196648

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 51 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472

Z-2204-2023
Recall number
Z-2204-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
24192 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

All lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYND41472, UDI/DI (EA) 10080196996537, UDI/DI (CS) 40080196996538

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

device · product 52 of 52

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O

Z-2205-2023
Recall number
Z-2205-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
4500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information

a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; All lots within expiry, distributed from Medline between December 2017 - May 2023:

Distribution pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.