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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96374

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

Open FDA event record

Event summary

Timeline bucket
February 11, 2025
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

19 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 19

Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749

Z-1435-2025
Recall number
Z-1435-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
340 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJRA0869A, 10889942531059 (each) 40889942531050 (case), Lot Number 20KBD382A; 2) Pack Number DYNJRA1749, 10193489829273 (each) 40193489829274 (case), Lot Number 24CMF477A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 2 of 19

Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ42873; 7) ANGIOGRAPHY PACK, Pack Number DYNJ57498; 8) ANGIOGRAPHY PACK, Pack Number DYNJ52167A; 9) ANGIOGRAPHY PACK, Pack Number DYNJV0173I; 10) ANGIOGRAPHY TRAY-LF, Pack Number DYNJ58722A; 11) CATH LAB PACK, Pack Number DYNJ42912F; 12) CATH LAB PK, Pack Number DYNJ35643B; 13) CATH PACK-LF, Pack Number DYNJ0367643Q; 14) CRMS ANGIO PACK-LF, Pack Number PHS616026002A; 15) DEPAUL ANGIO CATH PACK, Pack Number DYNJ24542L

Z-1436-2025
Recall number
Z-1436-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1939 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ50624A: UDI/DI 10889942474639 (each) 40889942474630 (case), Lot Number 20BDB393A; 2) Pack Number DYNJ30501F: UDI/DI 10889942806683 (each) 40889942806684 (case), Lot Number 21HBP134A; 3) Pack Number DYNJ0954970G: UDI/DI 10193489505634 (each) 40193489505635 (case), Lot Number 21GMA850A; 4) Pack Number DYNJ33597J: UDI/DI 10889942802012 (each) 40889942802013 (case), Lot Number 21IMD296A; 5) Pack Number DYNJ38120B: UDI/DI 10884389722145 (each) 40884389722146 (case), Lot Number 21BBI114A; 6) Pack Number DYNJ42873: UDI/DI 10888277011298 (each) 40888277011299 (case), Lot Number 23EBE560A; 7) Pack Number DYNJ57498: UDI/DI 10889942745746 (each) 40889942745747 (case), Lot Number 21AMA569A; 8) Pack Number DYNJ52167A: UDI/DI 10193489541106 (each) 40193489541107 (case), Lot Number 21GMB606A; 9) Pack Number DYNJV0173I: UDI/DI 10889942965021 (each) 40889942965022 (case), Lot Number 23CLA070A; 10) Pack Number DYNJ58722A: UDI/DI 10193489329698 (each) 40193489329699 (case), Lot Number 21IME955A; 11) Pack Number DYNJ42912F: UDI/DI 10193489785753 (each) 40193489785754 (case), Lot Number 23LBU921Z; 12) Pack Number DYNJ35643B: UDI/DI 10193489223712 (each) 40193489223713 (case), Lot Number 21BBG490A; 13) Pack Number DYNJ0367643Q: UDI/DI 10193489648614 (each) 40193489648615 (case), Lot Number 23EBE428A; 14) Pack Number PHS616026002A: UDI/DI 10889942429370 (each) 40889942429371 (case), Lot Number 23BBS889A; 15) Pack Number DYNJ24542L: UDI/DI 10193489651119 (each) 40193489651110 (case), Lot Number 20FBN798A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 3 of 19

Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ61266A; 6) ANGIOGRAPHY PACK-LF, Pack Number DYNJ35916N; 7) ARTERIOGRAM PACK, Pack Number DYNJ34442F; 8) CARDIAC CATH FEMORAL PACK, Pack Number DYNJ53588I; 9) CARDIAC CATH PACK, Pack Number DYNJ31733C; 10) CARDIAC CATH PACK, Pack Number DYNJ41315A; 11) CARDIAC CATH PACK-LF, Pack Number DYNJ0380198L; 12) CATH LAB PACK, Pack Number 0M-CP31796Q; 13) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 14) CATH LAB TRAY, Pack Number 00-401610J; 15) CHRISTUS SR CATH LAB PACK, Pack Number DYNJ60931C; 16) CRMC CATH LAB TRAY JUDKINS-LF, Pack Number DYNJ61088F; 17) CRMC NEURO ENDO HYBRID-LF, Pack Number DYNJ61101D; 18) EP PACK MORNINGSIDE, Pack Number DYNJ69301; 19) FEMORAL TRAY 2, Pack Number DYNJ68812C; 20) INTERVENTIONAL MINOR PACK, Pack Number DYNJ24615D; 21) INTERVENTIONAL PACK, Pack Number DYNJ54253; 22) INTERVENTIONAL RADIOLOGY PK-LF, Pack Number PHS605358025B; 23) MORNINGSIDE CARDIAC CATH, Pack Number DYNJ58339A; 24) OR INTERVENTIONAL PACK, Pack Number DYNJ46934A; 25) PACK,CARDIAC CATH, Pack Number DYNJ65481; 26) PK, RADIOLOGY-SPECIALS, Pack Number DYNJ59628C; 27) PTCA TRAY-LF, Pack Number DYNJ07252V; 28) RADIOLOGY PACK, Pack Number DYNJ45393A; 29) RR-ANGIOGRAPHY DRAPE PACK-LF, Pack Number DYNJ0608549M; 30) SPEC ANGIO PACK (SASJK)642-LF, Pack Number DYNJ47586F; 31) SPECIALS LINE PACK, Pack Number DYNJ69504; 32) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 33) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 34) UTHET TYLER ELECTROPHYSIOLOGY, Pack Number DYNJ68672C

Z-1437-2025
Recall number
Z-1437-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
9246 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ47718D: UDI/DI 10195327528331 (each) 40195327528332 (case), Lot Number 23LME887A; 2) Pack Number DYNJ69678: UDI/DI 10193489968156 (each) 40193489968157 (case), Lot Number 23EMD520A; 3) Pack Number DYNJ64936A: UDI/DI 10193489978759 (each) 40193489978750 (case), Lot Number 21LBW389A; 4) Pack Number DYNJ49621C: UDI/DI 10195327008581 (each) 40195327008582 (case), Lot Number 23LMG954A; 5) Pack Number DYNJ61266A: UDI/DI 10195327057763 (each) 40195327057764 (case), Lot Number 23GBF536A; 6) Pack Number DYNJ35916N: UDI/DI 10195327223977 (each) 40195327223978 (case), Lot Number 23EBE626A; 7) Pack Number DYNJ34442F: UDI/DI 10193489881424 (each) 40193489881425 (case), Lot Number 23LMG342A; 8) Pack Number DYNJ53588I: UDI/DI 10195327014001 (each) 40195327014002 (case), Lot Number 23EME005A; 9) Pack Number DYNJ31733C: UDI/DI 10889942875290 (each) 40889942875291 (case), Lot Number 21BBG459B; 10) Pack Number DYNJ41315A: UDI/DI 10888277907089 (each) 40888277907080 (case), Lot Number 22LBA182A; 11) Pack Number DYNJ0380198L: UDI/DI 10193489916478 (each) 40193489916479 (case), Lot Number 22GBH915A; 12) Pack Number 0M-CP31796Q: UDI/DI 10889942756483 (each) 40889942756484 (case), Lot Number 21HBP168A; 13) Pack Number DYNJ0194968AG: UDI/DI 10195327179557 (each) 40195327179558 (case), Lot Number 24AME980A; 14) Pack Number 00-401610J: UDI/DI 10889942731640 (each) 40889942731641 (case), Lot Number 23LBL085Z; 15) Pack Number DYNJ60931C: UDI/DI 10193489952940 (each) 40193489952941 (case), Lot Number 21JMI207A; 16) Pack Number DYNJ61088F: UDI/DI 10195327451585 (each) 40195327451586 (case), Lot Number 23LMG703A; 17) Pack Number DYNJ61101D: UDI/DI 10195327451813 (each) 40195327451814 (case), Lot Number 23HME348A; 18) Pack Number DYNJ69301: UDI/DI 10193489926101 (each) 40193489926102 (case), Lot Number 23CBL353A; 19) Pack Number DYNJ68812C: UDI/DI 10195327449452 (each) 40195327449453 (case), Lot Number 23KMC169A; 20) Pack Number DYNJ24615D: UDI/DI 10889942436057 (each) 40889942436058 (case), Lot Number 21JMF491A; 21) Pack Number DYNJ54253: UDI/DI 10889942474509 (each) 40889942474500 (case), Lot Number 20KBM762A; 22) Pack Number PHS605358025B: UDI/DI 10193489498998 (each) 40193489498999 (case), Lot Number 23FMD837A; 23) Pack Number DYNJ58339A: UDI/DI 10193489483147 (each) 40193489483148 (case), Lot Number 21EBP494A; 24) Pack Number DYNJ46934A: UDI/DI 10888277856998 (each) 40888277856999 (case), Lot Number 23BBR783A; 25) Pack Number DYNJ65481: UDI/DI 10193489280463 (each) 40193489280464 (case), Lot Number 23IMG363A; 26) Pack Number DYNJ59628C: UDI/DI 10193489813128 (each) 40193489813129 (case), Lot Number 23LBK499A; 27) Pack Number DYNJ07252V: UDI/DI 10193489744644 (each) 40193489744645 (case), Lot Number 22HBO256A; 28) Pack Number DYNJ45393A: UDI/DI 10889942188765 (each) 40889942188766 (case), Lot Number 20FMA718A; 29) Pack Number DYNJ0608549M: UDI/DI 10195327477387 (each) 40195327477388 (case), Lot Number 23LMD710A; 30) Pack Number DYNJ47586F: UDI/DI 10195327400156 (each) 40195327400157 (case), Lot Number 23LME689A; 31) Pack Number DYNJ69504: UDI/DI 10193489950243 (each) 40193489950244 (case), Lot Number 24ABA461Z; 32) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case), Lot Number 23HMB245A; 33) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case), Lot Number 23HMC543A; 34) Pack Number DYNJ68672C: UDI/DI 10195327191566 (each) 40195327191567 (case), Lot Number 23BBR790A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 4 of 19

Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C; 6) CARDIAC CATH PACK, Pack Number DYNJ61256A; 7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527; 8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C; 9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F; 10) CAROTID PACK, Pack Number DYNJ0810062AI; 11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T; 12) CATH PACK, Pack Number DYNJ59830A; 13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B; 14) CICC, Pack Number DYNJ53854A; 15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G; 16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235; 17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F; 18) EP DEVICE, Pack Number DYNJ65916B; 19) EP STUDY PACK-LF, Pack Number DYNJ38059A; 20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D; 21) GV OPEN HEART PACK, Pack Number DYNJ60618C; 22) HEART CABG CDS, Pack Number CDS983376Q; 23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226; 24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A; 25) LEX OPEN HEART, Pack Number DYNJ900968I; 26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C; 27) NIR PACK, Pack Number DYNJ63892A; 28) OPEN HEART, Pack Number DYNJ904261B; 29) OPEN HEART, Pack Number DYNJ904261B; 30) OPEN HEART, Pack Number DYNJ905021J; 31) OPEN HEART A PACK, Pack Number DYNJ04478R; 32) OPEN HEART ACC, Pack Number DYNJ23533D; 33) OPEN HEART CDS, Pack Number CDS840171AB; 34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N; 35) OPEN HEART PACK, Pack Number DYNJ45122C; 36) OPEN HEART PACK, Pack Number DYNJ55648; 37) OPEN HEART PACK, Pack Number DYNJ04381J; 38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M; 39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N; 40) OPEN HEART PART B PACK, Pack Number DYNJ43038N; 41) OPEN HEART SUPPLY, Pack Number DYNJ65641; 42) OPEN PACK, Pack Number DYNJ67442B; 43) PACEMAKER, Pack Number DYNJ59399I; 44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M; 45) PACEMAKER PACK, Pack Number DYNJ66165; 46) PACEMAKER PACK, Pack Number DYNJ41134B; 47) PACEMAKER PACK, Pack Number DYNJ61260A; 48) PACEMAKER PACK, Pack Number DYNJ60635; 49) PACEMAKER PACK, Pack Number DYNJ42602C; 50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J; 51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B; 52) PACEMAKER PACK-LF, Pack Number DYNJ53112B; 53) PACEMAKER PACK-LF, Pack Number DYNJ51844B; 54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R; 55) PEDI EP PACK, Pack Number DYNJ54750G; 56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F; 57) PK, OPEN HEART, Pack Number DYNJ44015B; 58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C; 59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N; 60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L; 61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P; 62) TAVR PACK, Pack Number DYNJ58386A; 63) THORACIC PACK, Pack Number DYNJ80309; 64) VASCULAR, Pack Number DYNJ45376G; 65) VASCULAR PACK, Pack Number DYNJ48288C; 66) VASCULAR PACK, Pack Number DYNJ54979; 67) VASCULAR PACK, Pack Number DYNJ64883C; 68) VASCULAR PACK, Pack Number DYNJ43945I; 69) VASCULAR PACK, Pack Number DYNJ43945I; 70) VASCULAR PACK, Pack Number DYNJ67426A; 71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C; 72) VASCULAR SUB, Pack Number DYNJ60681A; 73) VASCULAR SUB, Pack Number DYNJ60681A

Z-1438-2025
Recall number
Z-1438-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
3860 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A; 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Number 23LMD975A; 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case), Lot Number 22GBV822Z; 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case), Lot Number 22GMB113A; 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case), Lot Number 21JMG551A; 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case), Lot Number 23JBH403A; 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case), Lot Number 21LBJ158A; 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case), Lot Number 24AMF039A; 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case), Lot Number 23LMF122A; 10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 40193489866040 (case), Lot Number 22CMB582A; 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Number 22JBD481Z; 12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case), Lot Number 21EMF434A; 13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case), Lot Number 21LBD584A; 14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case), Lot Number 21GMB561A; 15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (case), Lot Number 23CBN679A; 16) Pack Number DYNJ56235: UDI/DI 10889942621552 (each) 40889942621553 (case), Lot Number 23EBD843A; 17) Pack Number DYNJ55482F: UDI/DI 10195327332273 (each) 40195327332274 (case), Lot Number 23BBS877A; 18) Pack Number DYNJ65916B: UDI/DI 10193489902044 (each) 40193489902045 (case), Lot Number 23JBT190A; 19) Pack Number DYNJ38059A: UDI/DI 10193489401110 (each) 40193489401111 (case), Lot Number 20LMF803A; 20) Pack Number DYNJ36931D: UDI/DI 10193489927559 (each) 40193489927550 (case), Lot Number 23BBS364Z; 21) Pack Number DYNJ60618C: UDI/DI 10193489475630 (each) 40193489475631 (case), Lot Number 22GMD148Z; 22) Pack Number CDS983376Q: UDI/DI 10195327379797 (each) 40195327379798 (case), Lot Number 23IBG370Z; 23) Pack Number DYNJ65226: UDI/DI 10193489253672 (each) 40193489253673 (case), Lot Number 20BDA909A; 24) Pack Number DYNJ59466A: UDI/DI 10193489562613 (each) 40193489562614 (case), Lot Number 21BBF996A; 25) Pack Number DYNJ900968I: UDI/DI 10193489453188 (each) 40193489453189 (case), Lot Number 22IBM300N; 26) Pack Number DYNJ54738C: UDI/DI 10193489778755 (each) 40193489778756 (case), Lot Number 21EBF317A; 27) Pack Number DYNJ63892A: UDI/DI 10195327176518 (each) 40195327176519 (case), Lot Number 23LME320A; 28) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22IBN057Z; 29) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22JBJ452Z; 30) Pack Number DYNJ905021J: UDI/DI 10195327281625 (each) 40195327281626 (case), Lot Number 23DBI088Z; 31) Pack Number DYNJ04478R: UDI/DI 10888277748835 (each) 40888277748836 (case), Lot Number 22GMA554A; 32) Pack Number DYNJ23533D: UDI/DI 10193489470659 (each) 40193489470650 (case), Lot Number 22GMC009A; 33) Pack Number CDS840171AB: UDI/DI 10195327167042 (each) 40195327167043 (case), Lot Number 22GMG011Z; 34) Pack Number DYNJ0382048N: UDI/DI 10195327537364 (each) 40195327537365 (case), Lot Number 23JBV598A; 35) Pack Number DYNJ45122C: UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 21EME856A; 36) Pack Number DYNJ55648: UDI/DI 10889942581900 (each) 40889942581901 (case), Lot Number 21LBN735A; 37) Pack Number DYNJ04381J: UDI/DI 10888277745155 (each) 40888277745156 (case), Lot Number 23GMB245A; 38) Pack Number DYNJ24300M: UDI/DI 10193489823608 (each) 40193489823609 (case), Lot Number 23FBL428A; 39) Pack Number DYNJ0369758N: UDI/DI 10193489501247 (each) 40193489501248 (case), Lot Number 22GBO541Z; 40) Pack Number DYNJ43038N: UDI/DI 10195327263911 (each) 40195327263912 (case), Lot Number 23EMD464A; 41) Pack Number DYNJ65641: UDI/DI 10193489282986 (each) 40193489282987 (case), Lot Number 21BBF660A; 42) Pack Number DYNJ67442B: UDI/DI 10195327133542 (each) 40195327133543 (case), Lot Number 23DBR515A; 43) Pack Number DYNJ59399I: UDI/DI 10195327442071 (each) 40195327442072 (case), Lot Number 23HMB191A; 44) Pack Number DYNJ0373237M: UDI/DI 10193489369014 (each) 40193489369015 (case), Lot Number 23LBU493Z; 45) Pack Number DYNJ66165: UDI/DI 10193489319729 (each) 40193489319720 (case), Lot Number 20DBP548A; 46) Pack Number DYNJ41134B: UDI/DI 10889942011643 (each) 40889942011644 (case), Lot Number 21BBI489A; 47) Pack Number DYNJ61260A: UDI/DI 10193489857481 (each) 40193489857482 (case), Lot Number 21HMF542A; 48) Pack Number DYNJ60635: UDI/DI 10193489518153 (each) 40193489518154 (case), Lot Number 21IMG997A; 49) Pack Number DYNJ42602C: UDI/DI 10195327019198 (each) 40195327019199 (case), Lot Number 23BBR329A; 50) Pack Number DYNJ32897J: UDI/DI 10193489648102 (each) 40193489648103 (case), Lot Number 20AKB914A; 51) Pack Number DYNJ39912B: UDI/DI 10889942705078 (each) 40889942705079 (case), Lot Number 21GMA579A; 52) Pack Number DYNJ53112B: UDI/DI 10193489650617 (each) 40193489650618 (case), Lot Number 21IMF023A; 53) Pack Number DYNJ51844B: UDI/DI 10889942615773 (each) 40889942615774 (case), Lot Number 21LME446A; 54) Pack Number DYNJ0854874R: UDI/DI 10195327094966 (each) 40195327094967 (case), Lot Number 22CMB704A; 55) Pack Number DYNJ54750G: UDI/DI 10195327021351 (each) 40195327021352 (case), Lot Number 22GBH035A; 56) Pack Number DYNJ22036F: UDI/DI 10889942528899 (each) 40889942528890 (case), Lot Number 20FBH674A; 57) Pack Number DYNJ44015B: UDI/DI 10193489215939 (each) 40193489215930 (case), Lot Number 23EMD927A; 58) Pack Number DYNJ45048C: UDI/DI 10193489808889 (each) 40193489808880 (case), Lot Number 21IMD394A; 59) Pack Number DYNJ0394805N: UDI/DI 10193489245240 (each) 40193489245241 (case), Lot Number 23LME396A; 60) Pack Number DYNJ33544L: UDI/DI 10195327279318 (each) 40195327279319 (case), Lot Number 23LMF755A; 61) Pack Number DYNJ0394730P: UDI/DI 10193489430943 (each) 40193489430944 (case), Lot Number 21LMG091A; 62) Pack Number DYNJ58386A: UDI/DI 10193489397468 (each) 40193489397469 (case), Lot Number 21VBB871A; 63) Pack Number DYNJ80309: UDI/DI 10195327023218 (each) 40195327023219 (case), Lot Number 23LMF645A; 64) Pack Number DYNJ45376G: UDI/DI 10195327209353 (each) 40195327209354 (case), Lot Number 23KMD075A; 65) Pack Number DYNJ48288C: UDI/DI 10888277745599 (each) 40888277745590 (case), Lot Number 21IMH225A; 66) Pack Number DYNJ54979: UDI/DI 10889942519910 (each) 40889942519911 (case), Lot Number 21LBL535Z; 67) Pack Number DYNJ64883C: UDI/DI 10193489369670 (each) 40193489369671 (case), Lot Number 23BBR373A; 68) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23GME703A; 69) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23HMC425A; 70) Pack Number DYNJ67426A: UDI/DI 10195327049317 (each) 40195327049318 (case), Lot Number 23HMC554A; 71) Pack Number DYNJ41863C: UDI/DI 10195327463632 (each) 40195327463633 (case), Lot Number 23HBW577A; 72) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 20EBI994A; 73) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 21BBI579A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 5 of 19

Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pack Number DYNJ0774005G; 6) PICC/RAD SPEC PROC 0906165-LF, Pack Number DYNJ32773G; 7) VAP PACK-LF, Pack Number PHS656578F

Z-1439-2025
Recall number
Z-1439-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
398

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ0826753O : UDI/DI 10193489384291 (each) 40193489384292 (case), Lot Number 23GMB253A; 2) Pack Number DYNJ56717A : UDI/DI 10889942897940 (each) 40889942897941 (case), Lot Number 21EBM603A; 3) Pack Number CVI5065 : UDI/DI 10195327504366 (each) 40195327504367 (case), Lot Number 23LMH242A; 4) Pack Number DYNJ46648D : UDI/DI 10193489755244 (each) 40193489755245 (case), Lot Number 20HMC528A; 5) Pack Number DYNJ0774005G : UDI/DI 10193489271485 (each) 40193489271486 (case), Lot Number 21EMA842Z; 6) Pack Number DYNJ32773G : UDI/DI 10193489766134 (each) 40193489766135 (case), Lot Number 21IMG907A; 7) Pack Number PHS656578F : UDI/DI 10889942804535 (each) 40889942804536 (case), Lot Number 20LKB006A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 6 of 19

Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

Z-1440-2025
Recall number
Z-1440-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
808 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ62734A: UDI/DI 10193489242225 (each) 40193489242226 (case), Lot Number 21IME904A; 2) Pack Number DYNJ44115A: UDI/DI 10889942308187 (each) 40889942308188 (case), Lot Number 21EMF484A; 3) Pack Number DYNJ68393A: UDI/DI 10193489939996 (each) 40193489939997 (case), Lot Number 22KBW583A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 7 of 19

Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ80438; 6) DONOR FREE FLAP PACK-LF, Pack Number DYNJ0426069N; 7) ENT PACK, Pack Number DYNJ50915B; 8) GENERAL LAPAROSCOPY PACK, Pack Number DYNJ63363G; 9) GENERAL LAPAROSCOPY PACK-LF, Pack Number DYNJ0415393J; 10) GENERAL LAPAROSCOPY PLUS, Pack Number DYNJ66729; 11) GERMANTOWN GENERAL LAP CHO, Pack Number DYNJ60998; 12) KOS LAPAROSCOPY PACK-LF, Pack Number DYNJ51663B; 13) LAP CHOLE, Pack Number DYNJ59943C; 14) LAP CHOLE, Pack Number DYNJ904625D; 15) LAP CHOLE, Pack Number DYNJ902780D; 16) LAP CHOLE I-LF, Pack Number DYNJ83414; 17) LAP CHOLE PACK, Pack Number DYNJ51502A; 18) LAP CHOLE PACK, Pack Number DYNJ16657G; 19) LAP CHOLE PACK, Pack Number DYNJ37370B; 20) LAP CHOLE PACK, Pack Number DYNJ26209N; 21) LAP CHOLE PACK, Pack Number DYNJ04581P; 22) LAP CHOLE PACK, Pack Number DYNJ67745A; 23) LAP CHOLE PACK-LF, Pack Number DYNJ09820J; 24) LAP CHOLE TRAY-LF, Pack Number DYNJ48884C; 25) LAPAROSCOPIC, Pack Number DYNJ57709B; 26) LAPAROSCOPIC COLORECTAL PACK, Pack Number DYNJ80172B; 27) LAPAROSCOPIC PACK, Pack Number DYNJ46550F; 28) LAPAROSCOPIC PACK, Pack Number DYNJ63472; 29) LAPAROSCOPY ESC, Pack Number DYNJ902455I; 30) LAPAROSCOPY PACK, Pack Number DYNJ61652; 31) LAPAROSCOPY PACK, Pack Number DYNJHS0235C; 32) LAPAROSCOPY PACK, Pack Number DYNJ21605J; 33) LAPAROTOMY PACK, Pack Number DYNJ52642F; 34) LAPAROTOMY PACK, Pack Number DYNJ59313B; 35) LEX CYSTO-TUR, Pack Number DYNJ902039F; 36) LUKENS MAJOR PACK, Pack Number DYNJ83049; 37) MAIN & ODS CYSTO PACK, Pack Number DYNJ66821A; 38) MAJOR BASIN PACK, Pack Number DYNJ16629D; 39) MAJOR LAPAROTOMY PACK, Pack Number DYNJ67695A; 40) MAJOR SINGLE BASIN W/GOWNS, Pack Number DYNJS3032; 41) MINOR ABDOMINAL, Pack Number DYNJ44675K; 42) MINOR PACK, Pack Number DYNJ46190G; 43) MINOR PACK, Pack Number DYNJ68885A; 44) MINOR PACK, Pack Number DYNJ45578B; 45) MINOR PACK, Pack Number DYNJ43784A; 46) MINOR PACK-LF, Pack Number DYNJ04690Y; 47) MINOR PROCEDURE PACK, Pack Number DYNJQ0629F; 48) MINOR PROCEDURE PACK, Pack Number DYNJ69256; 49) MINOR UROLOGY PACK, Pack Number DYNJ49310F; 50) MLD PACK, Pack Number DYNJ19521P; 51) MP LAP CHOLE, Pack Number DYNJ49947G; 52) NHCH GENERAL PACK, Pack Number DYNJ51573C; 53) NHCH LAPAROSCOPY PACK, Pack Number DYNJ51575B; 54) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 55) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 56) PED LAPAROTOMY PACK, Pack Number DYNJ55538B; 57) PK, URO-CYSTO, Pack Number DYNJ44022B; 58) RF LAP CHOLEPACK (LCLUI)642-LF, Pack Number DYNJ47704G; 59) ROBOT PROSTATECTOMY PACK, Pack Number DYNJ82688; 60) ROBOTIC PACK, Pack Number DYNJ82436A; 61) ROBOTICS PACK, Pack Number DYNJ83622; 62) RR-LAP NEPHRECTOMY PACK-LF, Pack Number DYNJ0785763L; 63) SC LAPAROSCOPY, Pack Number DYNJ49994I; 64) SCRIPPS HEALTH LAPAROSCOPY PK, Pack Number DYNJ66233A; 65) SMALL PROCEDURE PACK, Pack Number DYNJ55378C; 66) TUR / CYSTO PACK, Pack Number DYNJ69574A; 67) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 68) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 69) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J

Z-1441-2025
Recall number
Z-1441-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
11,774 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ40629B: UDI/DI 10888277778696 (each) 40888277778697 (case), Lot number 21EME542A; 2) Pack Number DYNJ67756A: UDI/DI 10193489847079 (each) 40193489847070 (case), Lot number 21LBH976A; 3) Pack Number DYNJ60934B: UDI/DI 10195327080785 (each) 40195327080786 (case), Lot number 22GBX458A; 4) Pack Number DYNJ61095D: UDI/DI 10195327452674 (each) 40195327452675 (case), Lot number 23LMF912A; 5) Pack Number DYNJ80438: UDI/DI 10195327038557 (each) 40195327038558 (case), Lot number 22GBI566A; 6) Pack Number DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310 (case), Lot number 23HMC076A; 7) Pack Number DYNJ50915B: UDI/DI 10193489213478 (each) 40193489213479 (case), Lot number 23EMC403A; 8) Pack Number DYNJ63363G: UDI/DI 10195327273330 (each) 40195327273331 (case), Lot number 23HMC803A; 9) Pack Number DYNJ0415393J: UDI/DI 10193489803273 (each) 40193489803274 (case), Lot number 21JMH176A; 10) Pack Number DYNJ66729: UDI/DI 10193489374933 (each) 40193489374934 (case), Lot number 22GBH503A; 11) Pack Number DYNJ60998: UDI/DI 10193489546149 (each) 40193489546140 (case), Lot number 21GMD619A; 12) Pack Number DYNJ51663B: UDI/DI 10889942965250 (each) 40889942965251 (case), Lot number 22CMG200A; 13) Pack Number DYNJ59943C: UDI/DI 10195327042547 (each) 40195327042548 (case), Lot number 21LBI099A; 14) Pack Number DYNJ904625D: UDI/DI 10193489419863 (each) 40193489419864 (case), Lot number 22IBD797Z; 15) Pack Number DYNJ902780D: UDI/DI 10193489221329 (each) 40193489221320 (case), Lot number 23GBO958Z; 16) Pack Number DYNJ83414: UDI/DI 10195327264949 (each) 40195327264940 (case), Lot number 23FMD507A; 17) Pack Number DYNJ51502A: UDI/DI 10193489686326 (each) 40193489686327 (case), Lot number 21BBD357A; 18) Pack Number DYNJ16657G: UDI/DI 10193489362619 (each) 40193489362610 (case), Lot number 21GMD931A; 19) Pack Number DYNJ37370B: UDI/DI 10889942223633 (each) 40889942223634 (case), Lot number 21IMF238A; 20) Pack Number DYNJ26209N: UDI/DI 10193489483161 (each) 40193489483162 (case), Lot number 22CMF620A; 21) Pack Number DYNJ04581P: UDI/DI 10193489555479 (each) 40193489555470 (case), Lot number 23DMB984A; 22) Pack Number DYNJ67745A: UDI/DI 10195327409401 (each) 40195327409402 (case), Lot number 24ABA563Z; 23) Pack Number DYNJ09820J: UDI/DI 10888277840928 (each) 40888277840929 (case), Lot number 21BBG608A; 24) Pack Number DYNJ48884C: UDI/DI 10193489476651 (each) 40193489476652 (case), Lot number 21LMF921A; 25) Pack Number DYNJ57709B: UDI/DI 10193489424065 (each) 40193489424066 (case), Lot number 23JBR204A; 26) Pack Number DYNJ80172B: UDI/DI 10195327359188 (each) 40195327359189 (case), Lot number 23FBM928A; 27) Pack Number DYNJ46550F: UDI/DI 10193489338812 (each) 40193489338813 (case), Lot number 20LKB332A; 28) Pack Number DYNJ63472: UDI/DI 10193489745597 (each) 40193489745598 (case), Lot number 23EBD908A; 29) Pack Number DYNJ902455I: UDI/DI 10193489309584 (each) 40193489309585 (case), Lot number 20HBJ365Z; 30) Pack Number DYNJ61652: UDI/DI 10193489586855 (each) 40193489586856 (case), Lot number 20JKA923A; 31) Pack Number DYNJHS0235C: UDI/DI 10889942635245 (each) 40889942635246 (case), Lot number 21JMA297A; 32) Pack Number DYNJ21605J: UDI/DI 10195327108700 (each) 40195327108701 (case), Lot number 22BMG822Z; 33) Pack Number DYNJ52642F: UDI/DI 10195327441302 (each) 40195327441303 (case), Lot number 23HMB247A; 34) Pack Number DYNJ59313B: UDI/DI 10195327248338 (each) 40195327248339 (case), Lot number 23LME174A; 35) Pack Number DYNJ902039F: UDI/DI 10195327390631 (each) 40195327390632 (case), Lot number 23GBO615Z; 36) Pack Number DYNJ83049: UDI/DI 10195327234300 (each) 40195327234301 (case), Lot number 23AMI041A; 37) Pack Number DYNJ66821A: UDI/DI 10193489974928 (each) 40193489974929 (case), Lot number 23IBJ792A; 38) Pack Number DYNJ16629D: UDI/DI 10889942870585 (each) 40889942870586 (case), Lot number 20HKB315A; 39) Pack Number DYNJ67695A: UDI/DI 10195327512200 (each) 40195327512201 (case), Lot number 23LMG985A; 40) Pack Number DYNJS3032: UDI/DI 10884389408407 (each) 40884389408408 (case), Lot number 23BBO868Z; 41) Pack Number DYNJ44675K: UDI/DI 10195327127480 (each) 40195327127481 (case), Lot number 23BDA249A; 42) Pack Number DYNJ46190G: UDI/DI 10195327213855 (each) 40195327213856 (case), Lot number 23EMD906A; 43) Pack Number DYNJ68885A: UDI/DI 10195327187453 (each) 40195327187454 (case), Lot number 23FBO338A; 44) Pack Number DYNJ45578B: UDI/DI 10195327059187 (each) 40195327059188 (case), Lot number 23GBD205A; 45) Pack Number DYNJ43784A: UDI/DI 10889942903047 (each) 40889942903048 (case), Lot number 23HME180A; 46) Pack Number DYNJ04690Y: UDI/DI 10195327381752 (each) 40195327381753 (case), Lot number 23DME413A; 47) Pack Number DYNJQ0629F: UDI/DI 10889942565559 (each) 40889942565550 (case), Lot number 21FBP134A; 48) Pack Number DYNJ69256: UDI/DI 10193489918151 (each) 40193489918152 (case), Lot number 21JMI098A; 49) Pack Number DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374 (case), Lot number 23LMF829A; 50) Pack Number DYNJ19521P: UDI/DI 10193489941197 (each) 40193489941198 (case), Lot number 21IMD905A; 51) Pack Number DYNJ49947G: UDI/DI 10193489474152 (each) 40193489474153 (case), Lot number 21GMD742A; 52) Pack Number DYNJ51573C: UDI/DI 10195327561222 (each) 40195327561223 (case), Lot number 23LMG544A; 53) Pack Number DYNJ51575B: UDI/DI 10195327132248 (each) 40195327132249 (case), Lot number 22JMB950A; 54) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD323A; 55) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD611A; 56) Pack Number DYNJ55538B: UDI/DI 10193489574630 (each) 40193489574631 (case), Lot number 21BBG139A; 57) Pack Number DYNJ44022B: UDI/DI 10193489429329 (each) 40193489429320 (case), Lot number 22DBR220Z; 58) Pack Number DYNJ47704G: UDI/DI 10195327380724 (each) 40195327380725 (case), Lot number 23FMF488A; 59) Pack Number DYNJ82688: UDI/DI 10195327202903 (each) 40195327202904 (case), Lot number 23LMG154A; 60) Pack Number DYNJ82436A: UDI/DI 10195327362607 (each) 40195327362608 (case), Lot number 23EMD052A; 61) Pack Number DYNJ83622: UDI/DI 10195327285753 (each) 40195327285754 (case), Lot number 23FBN812A; 62) Pack Number DYNJ0785763L: UDI/DI 10193489351095 (each) 40193489351096 (case), Lot number 21LMF965A; 63) Pack Number DYNJ49994I: UDI/DI 10195327065775 (each) 40195327065776 (case), Lot number 21LMF123A; 64) Pack Number DYNJ66233A: UDI/DI 10195327176600 (each) 40195327176601 (case), Lot number 23LME717A; 65) Pack Number DYNJ55378C: UDI/DI 10193489443776 (each) 40193489443777 (case), Lot number 22GBJ071A; 66) Pack Number DYNJ69574A: UDI/DI 10195327242473 (each) 40195327242474 (case), Lot number 22JBI116Z; 67) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22CMA803A; 68) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA579A; 69) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA581A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 8 of 19

Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G

Z-1442-2025
Recall number
Z-1442-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ44673G: UDI/DI 10195327127473 (each) 40195327127474 (case), Lot Number 22KDC145A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 9 of 19

Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

Z-1443-2025
Recall number
Z-1443-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
96 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ67356: UDI/DI 10193489887136 (each) 40193489887137 (case), Lot number 23GMF016A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 10 of 19

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385; 21) CT BASIC PACK, Pack Number DYNJ51617A; 22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I; 23) CYSTO, Pack Number DYNJ24351D; 24) CYSTO PACK, Pack Number DYNJ62359A; 25) DAVINCI PACK, Pack Number DYNJ04113C; 26) DUPYTRENS PACK, Pack Number DYNJ60496; 27) EH PACEMAKER PACK, Pack Number DYNJ55734C; 28) EVLT PACK, Pack Number DYNJ45997C; 29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G; 30) GENERAL BASIC PACK, Pack Number DYNJ82039; 31) GENERAL PURPOSE CV, Pack Number DYNJ904395F; 32) GENERAL UTILITY PACK, Pack Number DYNJ45093B; 33) HP DEVICE-LF, Pack Number DYNJ62255A; 34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B; 35) IR PACK, Pack Number DYNJ32080L; 36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857; 37) IR TABLE PACK II, Pack Number DYNJ56298B; 38) JVL-PACK TUNNELED, Pack Number DYNJ66065; 39) LITHOTOMY PACK, Pack Number DYNJ66490B; 40) LITHOTOMY PACK, Pack Number DYNJ65380A; 41) LOOP RECORDER PACK, Pack Number DYNJ53221B; 42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A; 43) MAJOR BASIN PACK, Pack Number DYNJ67484A; 44) MAJOR PACK, Pack Number DYNJ51996; 45) MAJOR PACK-LF, Pack Number DYNJ24599I; 46) MINI PACK, Pack Number DYNJ52305D; 47) MINI SET UP KIT, Pack Number DYNJ81562; 48) MINOR BASIN, Pack Number DYNJ43021B; 49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286; 50) MINOR PACK-LF, Pack Number DYNJ0551383P; 51) MINOR PK-LF, Pack Number DYNJ21408D; 52) MINOR WAKEFIELD, Pack Number DYNJ58872A; 53) MYELOGRAM TRAY, Pack Number DYNDH1775A; 54) OB PACK, Pack Number DYNJ32216B; 55) OPEN STERILE PACK, Pack Number DYNJ62104A; 56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B; 57) PACK URO-BASIC, Pack Number DYNJ38246A; 58) PACK,LTD BODY SSP, Pack Number DYNJ65488B; 59) PARACENTESIS, Pack Number DYNJ44505B; 60) PBMS NECK PACK-LF, Pack Number DYNJ64961A; 61) PEDI MAJOR PACK, Pack Number DYNJ40062K; 62) PEDI PK-LF, Pack Number DYNJ21240J; 63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B; 64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B; 65) PK, GEN-MINOR, Pack Number DYNJ59461C; 66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B; 67) PK, URO-CYSTO-MH, Pack Number DYNJ62501; 68) PK-GEN-BASIC, Pack Number DYNJ42382B; 69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B; 70) PODIATRY PACK, Pack Number DYNJ37297D; 71) PST PACK, Pack Number DYNJ62666; 72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J; 73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A; 74) SHUNT PACK-LF, Pack Number PHS967363W; 75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242; 76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X; 77) STANDARD ICL PACK-LF, Pack Number PHS895675B; 78) T & A PK-LF, Pack Number DYNJT2408C; 79) THORACIC PACK SHD, Pack Number DYNJ68416C; 80) TONSIL PACK-LF, Pack Number DYNJ0553334I; 81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I; 82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M; 83) VASECTOMY PACK, Pack Number DYNJ65326; 84) VASECTOMY PACK,

Z-1444-2025
Recall number
Z-1444-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
11,363 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJHS0136D: UDI/DI 10889942848973 (each) 40889942848974 (case), Lot Number 22JBC557Z; 2) Pack Number DYNJ56987B: UDI/DI 10889942868193 (each) 40889942868194 (case), Lot Number 21EBN072A; 3) Pack Number PHS170994005A: UDI/DI 10888277754379 (each) 40888277754370 (case), Lot Number 21IMG402A; 4) Pack Number DYNJ54836B: UDI/DI 10193489574128 (each) 40193489574129 (case), Lot Number 21BBH689A; 5) Pack Number DYNJ58678A: UDI/DI 10888277781207 (each) 40888277781208 (case), Lot Number 21GMF677A; 6) Pack Number DYNJ63532: UDI/DI 10193489748468 (each) 40193489748469 (case), Lot Number 22CMB574A; 7) Pack Number DYNJ81702: UDI/DI 10195327135447 (each) 40195327135448 (case), Lot Number 23CBF695A; 8) Pack Number DYNJ36595D: UDI/DI 10193489928976 (each) 40193489928977 (case), Lot Number 23CBL653A; 9) Pack Number DYNJ69250A: UDI/DI 10195327142315 (each) 40195327142316 (case), Lot Number 23HME051A; 10) Pack Number DYNJ50470C: UDI/DI 10889942922611 (each) 40889942922612 (case), Lot Number 23FME520A; 11) Pack Number DYNJ0115839A: UDI/DI 10193489901764 (each) 40193489901765 (case), Lot Number 23FME450A; 12) Pack Number PHS396134006A: UDI/DI 10889942694303 (each) 40889942694304 (case), Lot Number 23DDA331A; 13) Pack Number DYNJ20114Q: UDI/DI 10193489549249 (each) 40193489549240 (case), Lot Number 22JBF822Z; 14) Pack Number DYNJ0375705L: UDI/DI 10193489544138 (each) 40193489544139 (case), Lot Number 22GBP901M; 15) Pack Number DYNJ38051F: UDI/DI 10193489909319 (each) 40193489909310 (case), Lot Number 23EMC825A; 16) Pack Number DYNJ0161358B: UDI/DI 10889942213269 (each) 40889942213260 (case), Lot Number 23DDA354A; 17) Pack Number DYNJ50844B: UDI/DI 10889942883271 (each) 40889942883272 (case), Lot Number 22GMD340Z; 18) Pack Number DYNJ46776C: UDI/DI 10889942893218 (each) 40889942893219 (case), Lot Number 21BBE822A; 19) Pack Number DYNJ40640B: UDI/DI 10193489292145 (each) 40193489292146 (case), Lot Number 21IME326A; 20) Pack Number DYNJ39385: UDI/DI 10884389765067 (each) 40884389765068 (case), Lot Number 21IMD121A; 21) Pack Number DYNJ51617A: UDI/DI 10889942448616 (each) 40889942448617 (case), Lot Number 20LKB440A; 22) Pack Number DYNJ06672I: UDI/DI 10889942725830 (each) 40889942725831 (case), Lot Number 23BBU700A; 23) Pack Number DYNJ24351D: UDI/DI 10193489738841 (each) 40193489738842 (case), Lot Number 21LBD180A; 24) Pack Number DYNJ62359A: UDI/DI 10193489202571 (each) 40193489202572 (case), Lot Number 20AKB925A; 25) Pack Number DYNJ04113C: UDI/DI 10889942934102 (each) 40889942934103 (case), Lot Number 21EBP303A; 26) Pack Number DYNJ60496: UDI/DI 10193489506174 (each) 40193489506175 (case), Lot Number 22GBU071Z; 27) Pack Number DYNJ55734C: UDI/DI 10889942779093 (each) 40889942779094 (case), Lot Number 20FMA632A; 28) Pack Number DYNJ45997C: UDI/DI 10889942684366 (each) 40889942684367 (case), Lot Number 23GBF502A; 29) Pack Number DYNJ51799G: UDI/DI 10193489475944 (each) 40193489475945 (case), Lot Number 22CDB465A; 30) Pack Number DYNJ82039: UDI/DI 10195327163877 (each) 40195327163878 (case), Lot Number 23EBE702A; 31) Pack Number DYNJ904395F: UDI/DI 10193489701333 (each) 40193489701334 (case), Lot Number 22FBS141Z; 32) Pack Number DYNJ45093B: UDI/DI 10195327044213 (each) 40195327044214 (case), Lot Number 23BLB075A; 33) Pack Number DYNJ62255A: UDI/DI 10193489276671 (each) 40193489276672 (case), Lot Number 22GBU775A; 34) Pack Number DYNJ42231B: UDI/DI 10193489948165 (each) 40193489948166 (case), Lot Number 21HMB550A; 35) Pack Number DYNJ32080L: UDI/DI 10193489691900 (each) 40193489691901 (case), Lot Number 21BBJ386A; 36) Pack Number DYNJ64857: UDI/DI 10193489223361 (each) 40193489223362 (case), Lot Number 21IME211A; 37) Pack Number DYNJ56298B: UDI/DI 10193489415902 (each) 40193489415903 (case), Lot Number 21HME360A; 38) Pack Number DYNJ66065: UDI/DI 10193489319187 (each) 40193489319188 (case), Lot Number 23LMG850A; 39) Pack Number DYNJ66490B: UDI/DI 10195327472962 (each) 40195327472963 (case), Lot Number 23HMC391A; 40) Pack Number DYNJ65380A: UDI/DI 10195327418083 (each) 40195327418084 (case), Lot Number 23LMF918A; 41) Pack Number DYNJ53221B: UDI/DI 10193489922288 (each) 40193489922289 (case), Lot Number 23GMC211A; 42) Pack Number DYNJ48058A: UDI/DI 10193489325669 (each) 40193489325660 (case), Lot Number 21JMH979A; 43) Pack Number DYNJ67484A: UDI/DI 10195327020743 (each) 40195327020744 (case), Lot Number 23DME735A; 44) Pack Number DYNJ51996: UDI/DI 10889942233205 (each) 40889942233206 (case), Lot Number 21BBG178A; 45) Pack Number DYNJ24599I: UDI/DI 10193489315141 (each) 40193489315142 (case), Lot Number 21IMH674A; 46) Pack Number DYNJ52305D: UDI/DI 10195327028572 (each) 40195327028573 (case), Lot Number 22JBU974A; 47) Pack Number DYNJ81562: UDI/DI 10195327122539 (each) 40195327122530 (case), Lot Number 22JBW597A; 48) Pack Number DYNJ43021B: UDI/DI 10193489258851 (each) 40193489258852 (case), Lot Number 21GMC689A; 49) Pack Number DYNJ69286: UDI/DI 10193489922189 (each) 40193489922180 (case), Lot Number 23IMF699A; 50) Pack Number DYNJ0551383P: UDI/DI 10889942962143 (each) 40889942962144 (case), Lot Number 21GMB523A; 51) Pack Number DYNJ21408D: UDI/DI 10195327053642 (each) 40195327053643 (case), Lot Number 21LMF738A; 52) Pack Number DYNJ58872A: UDI/DI 10193489751871 (each) 40193489751872 (case), Lot Number 23JBW564A; 53) Pack Number DYNDH1775A: UDI/DI 10195327362218 (each) 40195327362219 (case), Lot Number 23LBM803Z; 54) Pack Number DYNJ32216B: UDI/DI 10193489546101 (each) 40193489546102 (case), Lot Number 21BBF074A; 55) Pack Number DYNJ62104A: UDI/DI 10193489763713 (each) 40193489763714 (case), Lot Number 23FBO390A; 56) Pack Number DYNJ60124B: UDI/DI 10193489982855 (each) 40193489982856 (case), Lot Number 21LMG031A; 57) Pack Number DYNJ38246A: UDI/DI 10884389757772 (each) 40884389757773 (case), Lot Number 23BBQ828A; 58) Pack Number DYNJ65488B: UDI/DI 10193489443646 (each) 40193489443647 (case), Lot Number 23LMG039A; 59) Pack Number DYNJ44505B: UDI/DI 10889942379248 (each) 40889942379249 (case), Lot Number 20BDB430A; 60) Pack Number DYNJ64961A: UDI/DI 10193489416039 (each) 40193489416030 (case), Lot Number 23IMF244A; 61) Pack Number DYNJ40062K: UDI/DI 10195327493325 (each) 40195327493326 (case), Lot Number 23LMF453A; 62) Pack Number DYNJ21240J: UDI/DI 10889942931378 (each) 40889942931379 (case), Lot Number 21IMH809A; 63) Pack Number DYNJ51725B: UDI/DI 10193489538731 (each) 40193489538732 (case), Lot Number 21KBJ357A; 64) Pack Number DYNJ55355B: UDI/DI 10195327173784 (each) 40195327173785 (case), Lot Number 23CBN280A; 65) Pack Number DYNJ59461C: UDI/DI 10195327510107 (each) 40195327510108 (case), Lot Number 24ABA333Z; 66) Pack Number DYNJ43754B: UDI/DI 10193489808964 (each) 40193489808965 (case), Lot Number 20HMD448A; 67) Pack Number DYNJ62501: UDI/DI 10193489664829 (each) 40193489664820 (case), Lot Number 21LBB961A; 68) Pack Number DYNJ42382B: UDI/DI 10195327253288 (each) 40195327253289 (case), Lot Number 23LMG144A; 69) Pack Number DYNJ41824B: UDI/DI 10889942933488 (each) 40889942933489 (case), Lot Number 21LBW098A; 70) Pack Number DYNJ37297D: UDI/DI 10193489566567 (each) 40193489566568 (case), Lot Number 21JMH963A; 71) Pack Number DYNJ62666: UDI/DI 10193489679663 (each) 40193489679664 (case), Lot Number 23BBR333A; 72) Pack Number DYNJ0785683J: UDI/DI 10193489709315 (each) 40193489709316 (case), Lot Number 23LMD781A; 73) Pack Number DYNJ43502A: UDI/DI 10193489767858 (each) 40193489767859 (case), Lot Number 21BBI542A; 74) Pack Number PHS967363W: UDI/DI 10889942924561 (each) 40889942924562 (case), Lot Number 21LME249A; 75) Pack Number DYNJ30242: UDI/DI 10080196785834 (each) 40080196785835 (case), Lot Number 23LMG145A; 76) Pack Number DYNJ0129513X: UDI/DI 10195327511876 (each) 40195327511877 (case), Lot Number 23LMG678A; 77) Pack Number PHS895675B: UDI/DI 10193489418316 (each) 40193489418317 (case), Lot Number 22IMB409A; 78) Pack Number DYNJT2408C: UDI/DI 10884389367643 (each) 40884389367644 (case), Lot Number 21AMA394A; 79) Pack Number DYNJ68416C: UDI/DI 10195327341688 (each) 40195327341689 (case), Lot Number 23LBS810Z; 80) Pack Number DYNJ0553334I: UDI/DI 10193489513646 (each) 40193489513647 (case), Lot Number 23HME093A; 81) Pack Number DYNJ0375928I: UDI/DI 10193489544220 (each) 40193489544221 (case), Lot Number 23CBB970A; 82) Pack Number DYNJ0416615M: UDI/DI 10195327518936 (each) 40195327518937 (case), Lot Number 24DMC685Z; 83) Pack Number DYNJ65326: UDI/DI 10193489267587 (each) 40193489267588 (case), Lot Number 21LBG918A; 84) Pack Number DYNJ84729: UDI/DI 10195327407247 (each) 40195327407248 (case), Lot Number 23GBV524A; 85) Pack Number DYNJ57459A: UDI/DI 10888277759596 (each) 40888277759597 (case), Lot Number 22GBE165A; 86) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case), Lot Number 22GDB223A; 87) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case), Lot Number 23EDA439A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 11 of 19

Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B

Z-1445-2025
Recall number
Z-1445-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ17328B: UDI/DI 10080196232895 (each) 40080196232896 (case), Lot Number 21LBA554A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 12 of 19

Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LABOR AND DELIVERY TRAY-LF, Pack Number DYNJ23054J; 7) OB DELIVERY-LF, Pack Number DYNJ40096F; 8) VAG DELIVERY PACK, Pack Number DYNJ83056; 9) VAGINAL DELIVERY, Pack Number DYNJ27939D; 10) VAGINAL DELIVERY PACK, Pack Number DYNJ25843C; 11) VAGINAL DELIVERY PACK, Pack Number DYNJ43395; 12) VAGINAL DELIVERY PACK-LF, Pack Number DYNJ0594115L

Z-1446-2025
Recall number
Z-1446-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1958 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case), Lot Number 23IMF426A; 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case), Lot Number 21JMG530A; 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case), Lot Number 21IMH700A; 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case), Lot Number 22IBG256Z; 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case), Lot Number 23HMC532A; 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case), Lot Number 22CMB444A; 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case), Lot Number 23IMF243A; 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case), Lot Number 22JMB827A; 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case), Lot Number 22LBE104A; 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 40889942853732 (case), Lot Number 21EBN038A; 11) Pack Number DYNJ43395: UDI/DI 10888277049444 (each) 40888277049445 (case), Lot Number 21LMG173A; 12) Pack Number DYNJ0594115L: UDI/DI 10193489382730 (each) 40193489382731 (case), Lot Number 20JKB018A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 13 of 19

Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack Number DYNJ80546B; 6) GYN 1 PACK, Pack Number DYNJ43441C; 7) GYN LAP, Pack Number DYNJ909936; 8) GYN LAPAROSCOPY PACK, Pack Number DYNJ63014A; 9) GYN LAPAROSCOPY PACK, Pack Number DYNJ51739B; 10) GYN LAPAROSCOPY PACK, Pack Number DYNJ84181; 11) GYN LAPAROSCOPY PACK, Pack Number SYNJ10073D; 12) GYN LAPAROSCOPY PACK-LF, Pack Number DYNJ0124452S; 13) LAP GYN PACK-LF, Pack Number PHS988229I; 14) LAPAROSCOPIC GYN PACK, Pack Number DYNJ47274J; 15) MOR GYN, Pack Number DYNJ902845K; 16) PELVISCOPY PACK-LF, Pack Number DYNJ0843760F; 17) ROBOTIC GYN, Pack Number DYNJ909233; 18) ROBOTIC RENAL PACK, Pack Number DYNJ50238C; 19) SCRIPPS SW ROBOTIC PACK, Pack Number DYNJ52564D; 20) SVMMC GYN ROBOTIC PACK, Pack Number DYNJ43782K; 21) TASC GYN LAP, Pack Number DYNJ49191B; 22) URO-GYN ROBOTIC PACK, Pack Number DYNJ37717K

Z-1447-2025
Recall number
Z-1447-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1711 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ61061D: UDI/DI 10195327451509 (each) 40195327451500 (case), Lot Number 23GMD257A; 2) Pack Number DYNJ0665103I: UDI/DI 10193489395211 (each) 40193489395212 (case), Lot Number 23ABM287A; 3) Pack Number DYNJ47762O: UDI/DI 10195327478742 (each) 40195327478743 (case), Lot Number 23IMF676A; 4) Pack Number DYNJ81236: UDI/DI 10195327096618 (each) 40195327096619 (case), Lot Number 23LMH303A; 5) Pack Number DYNJ80546B: UDI/DI 10195327211097 (each) 40195327211098 (case), Lot Number 23FBP444A; 6) Pack Number DYNJ43441C: UDI/DI 10193489323177 (each) 40193489323178 (case), Lot Number 21LBG879A; 7) Pack Number DYNJ909936: UDI/DI 10195327511203 (each) 40195327511204 (case), Lot Number 23JBI037Z; 8) Pack Number DYNJ63014A: UDI/DI 10193489245684 (each) 40193489245685 (case), Lot Number 20BDB396A; 9) Pack Number DYNJ51739B: UDI/DI 10889942975884 (each) 40889942975885 (case), Lot Number 22ABT041A; 10) Pack Number DYNJ84181: UDI/DI 10195327340360 (each) 40195327340361 (case), Lot Number 23KMC229A; 11) Pack Number SYNJ10073D: UDI/DI 10193489864540 (each) 40193489864541 (case), Lot Number 24ABA922Z; 12) Pack Number DYNJ0124452S: UDI/DI 10193489754216 (each) 40193489754217 (case), Lot Number 20HKB312A; 13) Pack Number PHS988229I: UDI/DI 10193489766035 (each) 40193489766036 (case), Lot Number 23GMB353A; 14) Pack Number DYNJ47274J: UDI/DI 10193489353631 (each) 40193489353632 (case), Lot Number 21IMG979A; 15) Pack Number DYNJ902845K: UDI/DI 10195327210199 (each) 40195327210190 (case), Lot Number 24AMD941Z; 16) Pack Number DYNJ0843760F: UDI/DI 10193489607833 (each) 40193489607834 (case), Lot Number 20BDB045A; 17) Pack Number DYNJ909233: UDI/DI 10195327310189 (each) 40195327310180 (case), Lot Number 23GBA187Z; 18) Pack Number DYNJ50238C: UDI/DI 10195327017484 (each) 40195327017485 (case), Lot Number 23HMC447A; 19) Pack Number DYNJ52564D: UDI/DI 10195327176426 (each) 40195327176427 (case), Lot Number 23GME685A; 20) Pack Number DYNJ43782K: UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Number 22HBO266M; 21) Pack Number DYNJ49191B: UDI/DI 10193489497489 (each) 40193489497480 (case), Lot Number 21JMH124A; 22) Pack Number DYNJ37717K: UDI/DI 10195327409753 (each) 40195327409754 (case), Lot Number 23GME305A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 14 of 19

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J

Z-1448-2025
Recall number
Z-1448-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
605 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case), Lot Number 20LMF902A; 2) Pack Number DYNJ48483B: UDI/DI 10193489659405 (each) 40193489659406 (case), Lot Number 20CKB746A; 3) Pack Number DYNJ61573: UDI/DI 10193489601077 (each) 40193489601078 (case), Lot Number 22CMB584A; 4) Pack Number DYNJ66801: UDI/DI 10193489384000 (each) 40193489384001 (case), Lot Number 22GBW063A; 5) Pack Number DYNJ0367951P: UDI/DI 10193489966923 (each) 40193489966924 (case), Lot Number 21IMH644A; 6) Pack Number DYNJ55345D: UDI/DI 10195327173722 (each) 40195327173723 (case), Lot Number 22GBJ830A; 7) Pack Number DYNJ04521J: UDI/DI 10193489555837 (each) 40193489555838 (case), Lot Number 21HMA851A; 8) Pack Number DYNJ32632F: UDI/DI 10193489888966 (each) 40193489888967 (case), Lot Number 21IMD959A; 9) Pack Number DYNJ65961B: UDI/DI 10193489984309 (each) 40193489984300 (case), Lot Number 23LMG679A; 10) Pack Number DYNJ38582J: UDI/DI 10193489528244 (each) 40193489528245 (case), Lot Number 21IMF094A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 15 of 19

Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q

Z-1449-2025
Recall number
Z-1449-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
268 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 16 of 19

Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A

Z-1450-2025
Recall number
Z-1450-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
570 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ65616C: UDI/DI 10195327470869 (each) 40195327470860 (case), Lot Number 23LMF217A; 2) Pack Number DYNJ61371A: UDI/DI 10193489796803 (each) 40193489796804 (case), Lot Number 21FMA140A; 3) Pack Number DYNJ20720C: UDI/DI 10884389620564 (each) 40884389620565 (case), Lot Number 21EMF438A; 4) Pack Number DYNJ0415776N: UDI/DI 10193489413984 (each) 40193489413985 (case), Lot Number 22CMD073A; 5) Pack Number PHS656483I: UDI/DI 10889942806768 (each) 40889942806769 (case), Lot Number 23GMB728A; 6) Pack Number DYNJ0046667A: UDI/DI 10889942160396 (each) 40889942160397 (case), Lot Number 22CMD979A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 17 of 19

Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT PACK, Pack Number DYNJ0417156G; 7) CATARACT PACK, Pack Number DYNJ60411A; 8) CATARACT PACK, Pack Number DYNJ52649F; 9) CATARACT PACK - 30843, Pack Number DYNJVB1076B; 10) CATARACT PACK-LF, Pack Number DYNJ0317858M; 11) CATARACT-LF, Pack Number DYNJ40081F; 12) ENT PACK, Pack Number DYNJ38916B; 13) EYE CATARACT PK, Pack Number DYNJ46557K; 14) EYE CATARACT PK, Pack Number DYNJ46557L; 15) EYE PACK, Pack Number DYNJ48800C; 16) EYE PACK, Pack Number DYNJ38494G; 17) EYE PACK, Pack Number DYNJ21134A; 18) EYE PACK 1, Pack Number DYNJHTEY01; 19) EYE PACK II-LF, Pack Number DYNJ50237A; 20) EYE PBM-LF, Pack Number DYNJ0190619G; 21) MZ GENERAL EYE PACK, Pack Number DYNJ66623A; 22) OCULAR PLASTICS, Pack Number DYNJ82032; 23) OPHTHALMOLOGY PACK, Pack Number DYNJ52885D; 24) OPHTHALMOLOGY PACK, Pack Number DYNJ52885F; 25) PK, OPHTH-RETINA, Pack Number DYNJ45046A; 26) PLASTIC PACK, Pack Number DYNJ82060A; 27) RETINAL DSC, Pack Number DYNJ68940A; 28) SMSC- EYE PACK HOSP&CLINIC-LF, Pack Number DYNJ0780084F; 29) STRABISMUS PACK-LF, Pack Number DYNJ0789014K; 30) RETINAL PACK, Pack Number LYN030REFCA; 31) EYE PACK WHITEWATER SC, Pack Number VAL038EPWSB

Z-1451-2025
Recall number
Z-1451-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
5,132 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJ0589795V: UDI/DI 10193489826722 (each) 40193489826723 (case), Lot Number 23LMF853A; 2) Pack Number DYNJ39921B: UDI/DI 10195327176365 (each) 40195327176366 (case), Lot Number 24AMI654A; 3) Pack Number DYNJ45662C: UDI/DI 10193489556636 (each) 40193489556637 (case), Lot Number 20EBE340A; 4) Pack Number DYNJ56056B: UDI/DI 10193489635348 (each) 40193489635349 (case), Lot Number 20JKA823A; 5) Pack Number DYNJ56553B: UDI/DI 10193489761962 (each) 40193489761963 (case), Lot Number 21IMG706A; 6) Pack Number DYNJ0417156G: UDI/DI 10889942067428 (each) 40889942067429 (case), Lot Number 22IMG784A; 7) Pack Number DYNJ60411A: UDI/DI 10195327221393 (each) 40195327221394 (case), Lot Number 22IMG811A; 8) Pack Number DYNJ52649F: UDI/DI 10195327357313 (each) 40195327357314 (case), Lot Number 23HME435A; 9) Pack Number DYNJVB1076B: UDI/DI 10195327062736 (each) 40195327062737 (case), Lot Number 23CLA046A; 10) Pack Number DYNJ0317858M: UDI/DI 10889942399789 (each) 40889942399780 (case), Lot Number 22IMD667A; 11) Pack Number DYNJ40081F: UDI/DI 10195327068370 (each) 40195327068371 (case), Lot Number 23IMC700A; 12) Pack Number DYNJ38916B: UDI/DI 10193489969863 (each) 40193489969864 (case), Lot Number 23HMC484A; 13) Pack Number DYNJ46557K: UDI/DI 10193489987225 (each) 40193489987226 (case), Lot Number 23FMF487A; 14) Pack Number DYNJ46557L: UDI/DI 10195327466879 (each) 40195327466870 (case), Lot Number 23LMF146A; 15) Pack Number DYNJ48800C: UDI/DI 10193489602173 (each) 40193489602174 (case), Lot Number 22IME600A; 16) Pack Number DYNJ38494G: UDI/DI 10193489404890 (each) 40193489404891 (case), Lot Number 22IMF477A; 17) Pack Number DYNJ21134A: UDI/DI 10080196818327 (each) 40080196818328 (case), Lot Number 23GMC030A; 18) Pack Number DYNJHTEY01: UDI/DI 10888277078758 (each) 40888277078759 (case), Lot Number 23HBT532A; 19) Pack Number DYNJ50237A: UDI/DI 10195327013967 (each) 40195327013968 (case), Lot Number 21KBW890A; 20) Pack Number DYNJ0190619G: UDI/DI 10193489442588 (each) 40193489442589 (case), Lot Number 21IMH127A; 21) Pack Number DYNJ66623A: UDI/DI 10195327001605 (each) 40195327001606 (case), Lot Number 22IMG395A; 22) Pack Number DYNJ82032: UDI/DI 10195327162689 (each) 40195327162680 (case), Lot Number 22JBO961A; 23) Pack Number DYNJ52885D: UDI/DI 10195327002077 (each) 40195327002078 (case), Lot Number 21JMH611A; 24) Pack Number DYNJ52885F: UDI/DI 10195327118877 (each) 40195327118878 (case), Lot Number 22IMH094A; 25) Pack Number DYNJ45046A: UDI/DI 10193489791112 (each) 40193489791113 (case), Lot Number 21FME768A; 26) Pack Number DYNJ82060A: UDI/DI 10195327370145 (each) 40195327370146 (case), Lot Number 23LMF289A; 27) Pack Number DYNJ68940A: UDI/DI 10195327326524 (each) 40195327326525 (case), Lot Number 23EMD688A; 28) Pack Number DYNJ0780084F: UDI/DI 10889942089598 (each) 40889942089599 (case), Lot Number 21AMA688A; 29) Pack Number DYNJ0789014K: UDI/DI 10193489954333 (each) 40193489954334 (case), Lot Number 21LMF629A; 30) Pack Number LYN030REFCA: UDI/DI 10195327152383 (each) 40195327152384 (case), Lot Number 22GBI949A; 31) Pack Number VAL038EPWSB: UDI/DI 10193489209976 (each) 40193489209977 (case), Lot Number 23GBE924A

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 18 of 19

Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 6) ARTHROSCOPY TRAY, Pack Number DYNJ46435A; 7) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50120D

Z-1452-2025
Recall number
Z-1452-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
186 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number DYNJHS0101I: UDI/DI 10888277046412 (each) 40888277046413 (case), Lot Number 21LBA780A; 2) Pack Number DYNJ0390808F: UDI/DI 10889942244591 (each) 40889942244592 (case), Lot Number 21JMG164A; 3) Pack Number DYNJ23150J: UDI/DI 10888277742239 (each) 40888277742230 (case), Lot Number 21LMF991A; 4) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case), Lot Number 22GBQ106M; 5) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case), Lot Number 22JBA123Z; 6) Pack Number DYNJ46435A: UDI/DI 10889942670901 (each) 40889942670902 (case), Lot Number 23LMG014A; 7) Pack Number DYNJ50120D: UDI/DI 10195327195656 (each) 40195327195657 (case), Lot Number 22JBG571Z

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 19 of 19

Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702

Z-1453-2025
Recall number
Z-1453-2025
Initiated
February 11, 2025
Classification
Class II
Status
Ongoing
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information

1) Pack Number 613034700: UDI/DI 10850009724004 (each) 40850009724005 (case), Lot Number 613034700; 2) Pack Number 613034702: UDI/DI 10850009724066 (each) 40850009724067 (case), Lot Number 613034702

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.