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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96510

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

Open FDA event record

Event summary

Timeline bucket
March 03, 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

34 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 34

Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;

Z-1586-2025
Recall number
Z-1586-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) MNS10395, UDI-DI: 10653160990185(each), 40653160990186(case), Lot Number: 24KBI045

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 2 of 34

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A

Z-1587-2025
Recall number
Z-1587-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ84116A, UDI-DI: 10198459062438(each), 40198459062439(case), Lot Number: 24IBH580

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 3 of 34

Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;

Z-1588-2025
Recall number
Z-1588-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ67577A, UDI-DI: 10193489980349(each), 40193489980340(case), Lot Number: 24JBX252; 2) DYNJ67576A, UDI-DI: 10193489980455(each), 40193489980456(case), Lot Number: 24JBX286

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 4 of 34

Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;

Z-1589-2025
Recall number
Z-1589-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ0371999G, UDI-DI: 10889942061037(each), 40889942061038(case), Lot Number: 24KBE129

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 5 of 34

Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C

Z-1590-2025
Recall number
Z-1590-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
2,118 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJHTCAD1, UDI-DI: 10888277087583(each), 40888277087584(case), Lot Number: 24JBS743; 2) DYNJ05350V, UDI-DI: 10193489316629(each), 40193489316620(case), Lot Number: 24JBU500; 3) DYNJ38144C, UDI-DI: 10193489854916(each), 40193489854917(case), Lot Number: 24KBD294

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 6 of 34

Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL MYELOGRAM, Model Number: DYNDH1228; 7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A; 8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 9) CATH LAB PACK, Model Number: DYNJ85070; 10) CT SCAN PACK, Model Number: DYNJ39515A; 11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ; 12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D; 13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974; 14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A; 15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020; 16) PORTACATH PACK, Model Number: DYNJ51240A; 17) RADIOLOGY PACK, Model Number: DYNJ43969; 18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I; 19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B

Z-1591-2025
Recall number
Z-1591-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
4022 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24IBS428; 2) DYNJ64354A, UDI-DI: 10195327156312(each), 40195327156313(case), Lot Number: 24JBM450; 3) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24JBM593; 4) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24JBN316; 5) DYNJ51338C, UDI-DI: 10193489241716(each), 40193489241717(case), Lot Number: 24JBN784; 6) DYNDH1228, UDI-DI: 10889942572007(each), 40889942572008(case), Lot Number: 24JBU509; 7) DYNJ83961A, UDI-DI: 10195327517748(each), 40195327517749(case), Lot Number: 24JBW818; 8) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24JBX138; 9) DYNJ85070, UDI-DI: 10195327455392(each), 40195327455393(case), Lot Number: 24JBY293; 10) DYNJ39515A, UDI-DI: 10889942753130(each), 40889942753131(case), Lot Number: 24KBA200; 11) 00-398650AJ, UDI-DI: 10195327330903(each), 40195327330904(case), Lot Number: 24KBA758; 12) DYNJ24812D, UDI-DI: 10884389653210(each), 40884389653211(case), Lot Number: 24KBB397; 13) DYNJ69974, UDI-DI: 10195327001117(each), 40195327001118(case), Lot Number: 24KBB454; 14) DYNJ69135A, UDI-DI: 10195327140496(each), 40195327140497(case), Lot Number: 24KBC186; 15) DYNJ45020, UDI-DI: 10888277086685(each), 40888277086686(case), Lot Number: 24KBC962; 16) DYNJ51240A, UDI-DI: 10889942493524(each), 40889942493525(case), Lot Number: 24KBE652; 17) DYNJ43969, UDI-DI: 10888277077089(each), 40888277077080(case), Lot Number: 24KBF965; 18) DYNJ41932I, UDI-DI: 10198459078699(each), 40198459078690(case), Lot Number: 24KBG499; 19) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24KBG961; 20) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24KBH847

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 7 of 34

Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V

Z-1592-2025
Recall number
Z-1592-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
3205 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ59310D, UDI-DI: 10195327402396(each), 40195327402397(case), Lot Number: 24IBB643; 2) DYNJ32436A, UDI-DI: 10884389686614(each), 40884389686615(case), Lot Number: 24IBG295; 3) DYNJ35586G, UDI-DI: 10193489663235(each), 40193489663236(case), Lot Number: 24IBG343; 4) DYNJ55343B, UDI-DI: 10195327478056(each), 40195327478057(case), Lot Number: 24IBG535; 5) DYNJ55343B, UDI-DI: 10195327478056(each), 40195327478057(case), Lot Number: 24IBH248; 6) DYNJ65027B, UDI-DI: 10193489471991(each), 40193489471992(case), Lot Number: 24IBH653; 7) DYNJ48196C, UDI-DI: 10193489712469(each), 40193489712460(case), Lot Number: 24IBL194; 8) DYNJ40480, UDI-DI: 10884389861196(each), 40884389861197(case), Lot Number: 24IBO308; 9) DYNJ900523B, UDI-DI: 10195327628703(each), 40195327628704(case), Lot Number: 24IBT180; 10) DYNJ19758I, UDI-DI: 10193489992328(each), 40193489992329(case), Lot Number: 24IBV182; 11) SYNJ10280C, UDI-DI: 10195327373597(each), 40195327373598(case), Lot Number: 24JBL521; 12) DYNJ48196C, UDI-DI: 10193489712469(each), 40193489712460(case), Lot Number: 24JBM305; 13) DYNJ27949F, UDI-DI: 10195327016104(each), 40195327016105(case), Lot Number: 24JBM849; 14) DYNJ41874C, UDI-DI: 10195327428914(each), 40195327428915(case), Lot Number: 24JBM893; 15) DYNJ83208A, UDI-DI: 10198459097065(each), 40198459097066(case), Lot Number: 24JBM959; 16) DYNJ56729, UDI-DI: 10889942676026(each), 40889942676027(case), Lot Number: 24JBT045; 17) DYNJCD0326, UDI-DI: 10193489203509(each), 40193489203500(case), Lot Number: 24JBU078; 18) DYNJ80084, UDI-DI: 10195327012014(each), 40195327012015(case), Lot Number: 24JBU113; 19) DYNJ39111A, UDI-DI: 10195327429744(each), 40195327429745(case), Lot Number: 24JBU159; 20) DYNJ25102I, UDI-DI: 10195327573812(each), 40195327573813(case), Lot Number: 24JBU436; 21) DYNJ62339, UDI-DI: 10193489646924(each), 40193489646925(case), Lot Number: 24JBV115; 22) DYNJ43278C, UDI-DI: 10193489957358(each), 40193489957359(case), Lot Number: 24JBV655; 23) DYNJ19758I, UDI-DI: 10193489992328(each), 40193489992329(case), Lot Number: 24JBW212; 24) DYNJ24735F, UDI-DI: 10198459014277(each), 40198459014278(case), Lot Number: 24JBW301; 25) DYNJ41683B, UDI-DI: 10198459124112(each), 40198459124113(case), Lot Number: 24JBW466; 26) DYNJ39379C, UDI-DI: 10193489611526(each), 40193489611527(case), Lot Number: 24JBX574; 27) DYNJ64016B, UDI-DI: 10193489258363(each), 40193489258364(case), Lot Number: 24KBA541; 28) DYNJ68019A, UDI-DI: 10198459163937(each), 40198459163938(case), Lot Number: 24KBC477; 29) DYNJ69108A, UDI-DI: 10195327025717(each), 40195327025718(case), Lot Number: 24KBC478; 30) DYNJHTCLP101A, UDI-DI: 10080196980154(each), 40080196980155(case), Lot Number: 24KBC947; 31) DYNJ38147C, UDI-DI: 10193489854862(each), 40193489854863(case), Lot Number: 24KBF070; 32) DYNDA1841, UDI-DI: 10889942522286(each), 40889942522287(case), Lot Number: 24KBF305; 33) DYNJ41925I, UDI-DI: 10198459160516(each), 40198459160517(case), Lot Number: 24KBG148; 34) DYNJ81951B, UDI-DI: 10198459003615(each), 40198459003616(case), Lot Number: 24KBG626; 35) DYNJ19538F, UDI-DI: 10195327658137(each), 40195327658138(case), Lot Number: 24KBG632; 36) CDS982026V, UDI-DI: 10195327657635(each), 40195327657636(case), Lot Number: 24KBP804; 37) CDS982026V, UDI-DI: 10195327657635(each), 40195327657636(case), Lot Number: 24LBI154

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 8 of 34

Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ82437A; 5) C LINE INSERTION CDS, Model Number: CDS980379J; 6) BSHR PICC LINE-LF, Model Number: DYNJ24529M; 7) ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; 8) PICC LINE PACK, Model Number: DYNJ55170F; 9) LINE INSERTION PACK, Model Number: DYNJ44949C; 10) RFA PACK, Model Number: DYNJ67899A; 11) KIT CENTRAL LINE INSERTION-LF, Model Number: PHS902533005; 12) INFANT LUMBAR PUNCTURE TRAY, Model Number: DYNDH1904; 13) PICC PACK-LF, Model Number: DYNJ55356A; 14) GENERAL TRAY, Model Number: DYNJ15652M; 15) CVR ENDOVENOUS PACK, Model Number: DYNJ80643; 16) LINE INSERTION TRAY, Model Number: DYNJ20803D

Z-1593-2025
Recall number
Z-1593-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
3808 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ44949C, UDI-DI: 10193489769227(each), 40193489769228(case), Lot Number: 24IBS279; 2) DYNJ41682C, UDI-DI: 10198459085512(each), 40198459085513(case), Lot Number: 24JBM452; 3) DYNJ81267A, UDI-DI: 10195327352356(each), 40195327352357(case), Lot Number: 24JBO094; 4) DYNJ82437A, UDI-DI: 10198459111006(each), 40198459111007(case), Lot Number: 24JBT077; 5) CDS980379J, UDI-DI: 10195327054908(each), 40195327054909(case), Lot Number: 24JBT886; 6) DYNJ24529M, UDI-DI: 10193489678284(each), 40193489678285(case), Lot Number: 24JBT947; 7) DYNJ65827, UDI-DI: 10193489298499(each), 40193489298490(case), Lot Number: 24JBW632; 8) DYNJ55170F, UDI-DI: 10195327614652(each), 40195327614653(case), Lot Number: 24KBB128; 9) DYNJ44949C, UDI-DI: 10193489769227(each), 40193489769228(case), Lot Number: 24KBB902; 10) DYNJ67899A, UDI-DI: 10198459071485(each), 40198459071486(case), Lot Number: 24KBC476; 11) PHS902533005, UDI-DI: 10889942043927(each), 40889942043928(case), Lot Number: 24KBD388; 12) DYNDH1904, UDI-DI: 10195327463779(each), 40195327463770(case), Lot Number: 24KBD507; 13) DYNJ55356A, UDI-DI: 10193489646191(each), 40193489646192(case), Lot Number: 24KBE301; 14) DYNJ15652M, UDI-DI: 10198459169410(each), 40198459169411(case), Lot Number: 24KBE666; 15) DYNJ80643, UDI-DI: 10195327055790(each), 40195327055791(case), Lot Number: 24KBH524; 16) DYNJ20803D, UDI-DI: 10889942553884(each), 40889942553885(case), Lot Number: 24KBJ200

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 9 of 34

Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 6) PHLEBECTOMY PACK, Model Number: DYNJ55215G; 7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D; 8) CAT BIOPSY PACK, Model Number: DYNJ62968; 9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D; 10) BIOPSY KIT, Model Number: DYNJ61130B

Z-1594-2025
Recall number
Z-1594-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
1126 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ68393A, UDI-DI: 10193489939996(each), 40193489939997(case), Lot Number: 24IBP745; 2) DYNJ81441B, UDI-DI: 10198459111105(each), 40198459111106(case), Lot Number: 24JBB770; 3) DYNJ68303, UDI-DI: 10193489821529(each), 40193489821520(case), Lot Number: 24JBU406; 4) DYNJ41678B, UDI-DI: 10198459124129(each), 40198459124120(case), Lot Number: 24JBW438; 5) DYNJ41678B, UDI-DI: 10198459124129(each), 40198459124120(case), Lot Number: 24JBW452; 6) DYNJ55215G, UDI-DI: 10193489925555(each), 40193489925556(case), Lot Number: 24KBC666; 7) DYNJ30078D, UDI-DI: 10889942138647(each), 40889942138648(case), Lot Number: 24KBD430; 8) DYNJ62968, UDI-DI: 10193489706239(each), 40193489706230(case), Lot Number: 24KBE699; 9) DYNJ53658D, UDI-DI: 10195327672140(each), 40195327672141(case), Lot Number: 24KBF023; 10) DYNJ61130B, UDI-DI: 10195327054588(each), 40195327054589(case), Lot Number: 24KBG714

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 10 of 34

Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model Number: DYNJ905551C

Z-1595-2025
Recall number
Z-1595-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
573 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ84880, UDI-DI: 10195327432140(each), 40195327432141(case), Lot Number: 24JBL926; 2) DYNJ56229A, UDI-DI: 10198459108105(each), 40198459108106(case), Lot Number: 24JBV124; 3) PHS807626F, UDI-DI: 10198459028045(each), 40198459028046(case), Lot Number: 24JBV611; 4) DYNJ41929D, UDI-DI: 10198459160585(each), 40198459160586(case), Lot Number: 24JBW877; 5) DYNJ51841C, UDI-DI: 10195327522186(each), 40195327522187(case), Lot Number: 24KBA623; 6) DYNJ905551C, UDI-DI: 10195327556099(each), 40195327556090(case), Lot Number: 24KBN091

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 11 of 34

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F

Z-1596-2025
Recall number
Z-1596-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ27333F, UDI-DI: 10888277055292(each), 40888277055293(case), Lot Number: 24KBH228

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 12 of 34

Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914

Z-1597-2025
Recall number
Z-1597-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
9216 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24IBE758; 2) DYNJ66514, UDI-DI: 10193489359282(each), 40193489359283(case), Lot Number: 24IBE817; 3) DYNJ67775A, UDI-DI: 10193489996258(each), 40193489996259(case), Lot Number: 24IBG346; 4) DYNJ83158, UDI-DI: 10195327236885(each), 40195327236886(case), Lot Number: 24IBG449; 5) DYNJ0634878I, UDI-DI: 10195327694500(each), 40195327694501(case), Lot Number: 24IBG548; 6) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24IBG570; 7) DYNJ44525C, UDI-DI: 10193489232042(each), 40193489232043(case), Lot Number: 24IBG608; 8) DYNJ44391K, UDI-DI: 10195327457648(each), 40195327457649(case), Lot Number: 24IBG848; 9) DYNJ49300D, UDI-DI: 10193489297287(each), 40193489297288(case), Lot Number: 24IBH734; 10) DYNJ61555B, UDI-DI: 10195327608101(each), 40195327608102(case), Lot Number: 24IBH769; 11) DYNJ57287A, UDI-DI: 10193489854152(each), 40193489854153(case), Lot Number: 24IBH959; 12) DYNJ36720F, UDI-DI: 10198459079306(each), 40198459079307(case), Lot Number: 24IBQ081; 13) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24IBQ933; 14) DYNJ36516, UDI-DI: 10884389544112(each), 40884389544113(case), Lot Number: 24IBR105; 15) DYNJ59502B, UDI-DI: 10193489372939(each), 40193489372930(case), Lot Number: 24IBR121; 16) DYNJ80790, UDI-DI: 10195327079482(each), 40195327079483(case), Lot Number: 24IBR337; 17) DYNJ57583, UDI-DI: 10889942755332(each), 40889942755333(case), Lot Number: 24IBR873; 18) DYNJ84876, UDI-DI: 10195327431778(each), 40195327431779(case), Lot Number: 24IBR895; 19) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24IBS352; 20) DYNJ908452C, UDI-DI: 10195327610937(each), 40195327610938(case), Lot Number: 24JBD799; 21) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 24JBF130; 22) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24JBK654; 23) DYNJ905762, UDI-DI: 10193489507966(each), 40193489507967(case), Lot Number: 24JBK682; 24) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBK897; 25) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24JBM367; 26) DYNJ59447A, UDI-DI: 10193489707663(each), 40193489707664(case), Lot Number: 24JBM926; 27) DYNJ26441R, UDI-DI: 10198459085888(each), 40198459085889(case), Lot Number: 24JBN335; 28) DYNJ58408A, UDI-DI: 10889942969029(each), 40889942969020(case), Lot Number: 24JBN611; 29) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24JBN781; 30) DYNJ61196A, UDI-DI: 10195327604240(each), 40195327604241(case), Lot Number: 24JBN797; 31) DYNJ66178D, UDI-DI: 10198459100307(each), 40198459100308(case), Lot Number: 24JBN811; 32) DYNJ37551A, UDI-DI: 10888277585720(each), 40888277585721(case), Lot Number: 24JBT022; 33) DYNJ68872F, UDI-DI: 10198459079269(each), 40198459079260(case), Lot Number: 24JBT065; 34) DYNJ50301C, UDI-DI: 10198459052330(each), 40198459052331(case), Lot Number: 24JBT456; 35) DYNJ40498B, UDI-DI: 10193489806779(each), 40193489806770(case), Lot Number: 24JBV199; 36) DYNJ46869A, UDI-DI: 10198459069949(each), 40198459069940(case), Lot Number: 24JBV309; 37) DYNJ58727D, UDI-DI: 10198459048425(each), 40198459048426(case), Lot Number: 24JBV608; 38) DYNJ45171C, UDI-DI: 10889942485260(each), 40889942485261(case), Lot Number: 24JBV814; 39) DYNJ56543J, UDI-DI: 10195327453602(each), 40195327453603(case), Lot Number: 24JBW129; 40) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24JBW183; 41) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24JBW623; 42) DYNJ40139D, UDI-DI: 10195327663506(each), 40195327663507(case), Lot Number: 24JBX313; 43) DYNJ32099A, UDI-DI: 10195327610890(each), 40195327610891(case), Lot Number: 24JBY276; 44) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBY278; 45) DYNJ53573A, UDI-DI: 10193489201635(each), 40193489201636(case), Lot Number: 24JBY404; 46) DYNJCH908, UDI-DI: 10193489393347(each), 40193489393348(case), Lot Number: 24KBA907; 47) DYNJ47481F, UDI-DI: 10195327067335(each), 40195327067336(case), Lot Number: 24KBB421; 48) DYNJ81479A, UDI-DI: 10195327378370(each), 40195327378371(case), Lot Number: 24KBB455; 49) DYNJ22357K, UDI-DI: 10193489926736(each), 40193489926737(case), Lot Number: 24KBB793; 50) DYNJ39317B, UDI-DI: 10889942775729(each), 40889942775720(case), Lot Number: 24KBC590; 51) DYNJ54321D, UDI-DI: 10195327679323(each), 40195327679324(case), Lot Number: 24KBC663; 52) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24KBC754; 53) DYNJ42451B, UDI-DI: 10193489740318(each), 40193489740319(case), Lot Number: 24KBC910; 54) DYNJ53348C, UDI-DI: 10195327453565(each), 40195327453566(case), Lot Number: 24KBD155; 55) DYNJ58596B, UDI-DI: 10195327635947(each), 40195327635948(case), Lot Number: 24KBD243; 56) DYNJ56262, UDI-DI: 10889942624331(each), 40889942624332(case), Lot Number: 24KBD661; 57) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24KBE334; 58) DYNJ68417C, UDI-DI: 10195327341633(each), 40195327341634(case), Lot Number: 24KBE396; 59) DYNJ48595, UDI-DI: 10888277915183(each), 40888277915184(case), Lot Number: 24KBE590; 60) DYNJ52611, UDI-DI: 10889942300853(each), 40889942300854(case), Lot Number: 24KBF355; 61) DYNJ81897B, UDI-DI: 10198459155710(each), 40198459155711(case), Lot Number: 24KBF577; 62) DYNJ43390A, UDI-DI: 10889942670321(each), 40889942670322(case), Lot Number: 24KBG019; 63) DYNJ34728D, UDI-DI: 10198459061851(each), 40198459061852(case), Lot Number: 24KBG035; 64) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24KBG072; 65) DYNJ41771C, UDI-DI: 10889942599189(each), 40889942599180(case), Lot Number: 24KBG178; 66) DYNJ68679B, UDI-DI: 10195327129095(each), 40195327129096(case), Lot Number: 24KBG186; 67) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24KBG371; 68) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24KBG399; 69) DYNJ83603, UDI-DI: 10195327284886(each), 40195327284887(case), Lot Number: 24KBG953; 70) DYNJ32247, UDI-DI: 10884389203873(each), 40884389203874(case), Lot Number: 24KBG965; 71) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24KBG993; 72) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24KBG996; 73) DYNJ25600L, UDI-DI: 10889942686247(each), 40889942686248(case), Lot Number: 24KBH226; 74) DYNJ38978C, UDI-DI: 10195327583590(each), 40195327583591(case), Lot Number: 24KBH242; 75) DYNJ50870D, UDI-DI: 10195327165666(each), 40195327165667(case), Lot Number: 24KBH280; 76) DYNJS0702, UDI-DI: 10080196798728(each), 40080196798729(case), Lot Number: 24KBI176; 77) DYNJ902836F, UDI-DI: 10198459002816(each), 40198459002817(case), Lot Number: 24KBI638; 78) DYNJ66039B, UDI-DI: 10195327151997(each), 40195327151998(case), Lot Number: 24KBL783; 79) DYNJ907844D, UDI-DI: 10195327387334(each), 40195327387335(case), Lot Number: 24KBP945; 80) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24LBA080

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 13 of 34

Refer to RES

Z-1598-2025
Recall number
Z-1598-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
14760 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ84990, UDI-DI: 10195327444068(each), 40195327444069(case), Lot Number: 24IBE926; 2) DYNJ45711B, UDI-DI: 10193489856149(each), 40193489856140(case), Lot Number: 24IBE981; 3) DYNJ45266B, UDI-DI: 10193489852417(each), 40193489852418(case), Lot Number: 24IBF031; 4) DYNJ80737B, UDI-DI: 10198459050855(each), 40198459050856(case), Lot Number: 24IBF165; 5) DYNJ67785A, UDI-DI: 10193489945638(each), 40193489945639(case), Lot Number: 24IBG441; 6) DYNJ49675F, UDI-DI: 10198459113529(each), 40198459113520(case), Lot Number: 24IBG617; 7) DYNJ0579176B, UDI-DI: 10889942429844(each), 40889942429845(case), Lot Number: 24IBG732; 8) DYNJ23615D, UDI-DI: 10193489587012(each), 40193489587013(case), Lot Number: 24IBG752; 9) DYNJ44752D, UDI-DI: 10195327322342(each), 40195327322343(case), Lot Number: 24IBG844; 10) DYNJ83155, UDI-DI: 10195327236854(each), 40195327236855(case), Lot Number: 24IBH261; 11) DYNJ83423, UDI-DI: 10195327265410(each), 40195327265411(case), Lot Number: 24IBH595; 12) DYNJ64257C, UDI-DI: 10195327449445(each), 40195327449446(case), Lot Number: 24IBH738; 13) DYNJ30587I, UDI-DI: 10198459078866(each), 40198459078867(case), Lot Number: 24IBM219; 14) DYNJ58655B, UDI-DI: 10198459027475(each), 40198459027476(case), Lot Number: 24IBQ285; 15) DYNJ49308F, UDI-DI: 10195327631178(each), 40195327631179(case), Lot Number: 24IBQ350; 16) DYNJ46736B, UDI-DI: 10889942559312(each), 40889942559313(case), Lot Number: 24IBQ975; 17) DYNJ27547B, UDI-DI: 10198459093616(each), 40198459093617(case), Lot Number: 24IBR473; 18) DYNJ14143J, UDI-DI: 10195327464806(each), 40195327464807(case), Lot Number: 24IBR483; 19) DYNJ80819B, UDI-DI: 10195327428983(each), 40195327428984(case), Lot Number: 24IBR559; 20) DYNJ47687A, UDI-DI: 10888277816879(each), 40888277816870(case), Lot Number: 24IBR569; 21) DYNJ86034A, UDI-DI: 10198459031649(each), 40198459031640(case), Lot Number: 24IBR630; 22) DYNJ909127F, UDI-DI: 10198459055423(each), 40198459055424(case), Lot Number: 24IBS115; 23) SYNJ10079G, UDI-DI: 10195327246822(each), 40195327246823(case), Lot Number: 24IBS269; 24) DYNJ58701B, UDI-DI: 10198459131592(each), 40198459131593(case), Lot Number: 24IBS283; 25) DYNJ83841A, UDI-DI: 10195327574314(each), 40195327574315(case), Lot Number: 24IBS297; 26) DYNJ40120B, UDI-DI: 10193489981353(each), 40193489981354(case), Lot Number: 24IBS349; 27) CDS982937O, UDI-DI: 10193489965483(each), 40193489965484(case), Lot Number: 24IBU511; 28) DYNJ58459A, UDI-DI: 10888277739642(each), 40888277739643(case), Lot Number: 24IBV583; 29) DYNJ50035F, UDI-DI: 10195327436070(each), 40195327436071(case), Lot Number: 24IBV702; 30) DYNJ900279F, UDI-DI: 10195327577568(each), 40195327577569(case), Lot Number: 24JBH126; 31) DYNJ63088B, UDI-DI: 10195327358938(each), 40195327358939(case), Lot Number: 24JBL176; 32) DYNJ46736B, UDI-DI: 10889942559312(each), 40889942559313(case), Lot Number: 24JBM344; 33) DYNJ39905A, UDI-DI: 10888277801912(each), 40888277801913(case), Lot Number: 24JBM389; 34) DYNJ46248F, UDI-DI: 10195327293482(each), 40195327293483(case), Lot Number: 24JBM542; 35) CDS981214A, UDI-DI: 10884389043158(each), 40884389043159(case), Lot Number: 24JBM651; 36) DYNJ14102J, UDI-DI: 10193489930450(each), 40193489930451(case), Lot Number: 24JBM843; 37) DYNJ41815B, UDI-DI: 10193489636017(each), 40193489636018(case), Lot Number: 24JBM885; 38) DYNJ41952D, UDI-DI: 10193489576221(each), 40193489576222(case), Lot Number: 24JBM895; 39) DYNJ41961D, UDI-DI: 10195327128890(each), 40195327128891(case), Lot Number: 24JBM897; 40) DYNJ53404B, UDI-DI: 10889942796496(each), 40889942796497(case), Lot Number: 24JBM915; 41) DYNJ50018B, UDI-DI: 10889942851133(each), 40889942851134(case), Lot Number: 24JBN056; 42) DYNJ41939B, UDI-DI: 10193489675733(each), 40193489675734(case), Lot Number: 24JBN277; 43) DYNJ44555J, UDI-DI: 10198459048197(each), 40198459048198(case), Lot Number: 24JBN612; 44) DYNJS0302, UDI-DI: 10080196798711(each), 40080196798712(case), Lot Number: 24JBN666; 45) DYNJ80792, UDI-DI: 10195327079505(each), 40195327079506(case), Lot Number: 24JBN817; 46) DYNJ67586A, UDI-DI: 10198459002199(each), 40198459002190(case), Lot Number: 24JBO078; 47) DYNJ57529F, UDI-DI: 10195327206390(each), 40195327206391(case), Lot Number: 24JBS815; 48) DYNJ44753G, UDI-DI: 10195327322359(each), 40195327322350(case), Lot Number: 24JBT889; 49) DYNJ80737B, UDI-DI: 10198459050855(each), 40198459050856(case), Lot Number: 24JBU018; 50) DYNJ80093, UDI-DI: 10195327010706(each), 40195327010707(case), Lot Number: 24JBU072; 51) DYNJ84446, UDI-DI: 10195327365257(each), 40195327365258(case), Lot Number: 24JBU122; 52) DYNJ56405C, UDI-DI: 10198459004520(each), 40198459004521(case), Lot Number: 24JBU143; 53) DYNJS0908, UDI-DI: 10080196986972(each), 40080196986973(case), Lot Number: 24JBU213; 54) DYNJ36184B, UDI-DI: 10884389640401(each), 40884389640402(case), Lot Number: 24JBV036; 55) DYNJ84990, UDI-DI: 10195327444068(each), 40195327444069(case), Lot Number: 24JBV135; 56) DYNJ68529C, UDI-DI: 10195327341190(each), 40195327341191(case), Lot Number: 24JBV596; 57) DYNJ23615D, UDI-DI: 10193489587012(each), 40193489587013(case), Lot Number: 24JBV598; 58) DYNJ26597K, UDI-DI: 10195327627645(each), 40195327627646(case), Lot Number: 24JBV677; 59) DYNJ82943, UDI-DI: 10195327218843(each), 40195327218844(case), Lot Number: 24JBW194; 60) DYNJ48896, UDI-DI: 10888277951167(each), 40888277951168(case), Lot Number: 24JBW459; 61) DYNJ83247, UDI-DI: 10195327251574(each), 40195327251575(case), Lot Number: 24JBW782; 62) DYNJ50465D, UDI-DI: 10195327287290(each), 40195327287291(case), Lot Number: 24JBX122; 63) DYNJ58655B, UDI-DI: 10198459027475(each), 40198459027476(case), Lot Number: 24JBX134; 64) DYNJ68411B, UDI-DI: 10195327341312(each), 40195327341313(case), Lot Number: 24JBX166; 65) CDS982937O, UDI-DI: 10193489965483(each), 40193489965484(case), Lot Number: 24JBX334; 66) DYNJ50843, UDI-DI: 10889942031573(each), 40889942031574(case), Lot Number: 24JBY226; 67) DYNJ908898B, UDI-DI: 10195327690939(each), 40195327690930(case), Lot Number: 24KBA038; 68) DYNJ63692B, UDI-DI: 10193489883107(each), 40193489883108(case), Lot Number: 24KBA661; 69) DYNJ909127F, UDI-DI: 10198459055423(each), 40198459055424(case), Lot Number: 24KBA834; 70) DYNJ40136B, UDI-DI: 10195327663483(each), 40195327663484(case), Lot Number: 24KBB754; 71) DYNJ50035F, UDI-DI: 10195327436070(each), 40195327436071(case), Lot Number: 24KBB778; 72) DYNJ49308F, UDI-DI: 10195327631178(each), 40195327631179(case), Lot Number: 24KBB826; 73) DYNJ53510C, UDI-DI: 10195327629144(each), 40195327629145(case), Lot Number: 24KBB851; 74) DYNJS0310, UDI-DI: 10080196942589(each), 40080196942580(case), Lot Number: 24KBB859; 75) DYNJ41800G, UDI-DI: 10195327468798(each), 40195327468799(case), Lot Number: 24KBC609; 76) DYNJ48762A, UDI-DI: 10193489488456(each), 40193489488457(case), Lot Number: 24KBC636; 77) DYNJ49249, UDI-DI: 10888277826120(each), 40888277826121(case), Lot Number: 24KBC638; 78) DYNJ69889B, UDI-DI: 10195327480479(each), 40195327480470(case), Lot Number: 24KBC777; 79) DYNJ84876A, UDI-DI: 10198459165917(each), 40198459165918(case), Lot Number: 24KBC847; 80) DYNJ64078A, UDI-DI: 10198459081248(each), 40198459081249(case), Lot Number: 24KBD253; 81) DYNJ80265B, UDI-DI: 10195327374938(each), 40195327374939(case), Lot Number: 24KBD327; 82) DYNJ36488I, UDI-DI: 10193489947946(each), 40193489947947(case), Lot Number: 24KBD827; 83) DYNJ41939B, UDI-DI: 10193489675733(each), 40193489675734(case), Lot Number: 24KBD842; 84) DYNJ85145, UDI-DI: 10195327466053(each), 40195327466054(case), Lot Number: 24KBE065; 85) DYNJ907536D, UDI-DI: 10198459104398(each), 40198459104399(case), Lot Number: 24KBE213; 86) DYNJ51836, UDI-DI: 10889942216642(each), 40889942216643(case), Lot Number: 24KBE294; 87) DYNJ61852B, UDI-DI: 10195327211448(each), 40195327211449(case), Lot Number: 24KBE319; 88) DYNJ47687A, UDI-DI: 10888277816879(each), 40888277816870(case), Lot Number: 24KBE434; 89) DYNJ51262C, UDI-DI: 10193489958201(each), 40193489958202(case), Lot Number: 24KBF353; 90) DYNJ81896B, UDI-DI: 10198459155741(each), 40198459155742(case), Lot Number: 24KBF571; 91) DYNJ42117A, UDI-DI: 10195327285777(each), 40195327285778(case), Lot Number: 24KBF961; 92) DYNJ53500D, UDI-DI: 10198459086427(each), 40198459086428(case), Lot Number: 24KBF969; 93) DYNJ46248F, UDI-DI: 10195327293482(each), 40195327293483(case), Lot Number: 24KBG033; 94) DYNJ01119D, UDI-DI: 10889942663057(each), 40889942663058(case), Lot Number: 24KBG043; 95) CDS760086R, UDI-DI: 10195327164775(each), 40195327164776(case), Lot Number: 24KBG197; 96) DYNJ50018C, UDI-DI: 10198459186448(each), 40198459186449(case), Lot Number: 24KBG841; 97) DYNJ63246B, UDI-DI: 10193489487435(each), 40193489487436(case), Lot Number: 24KBG871; 98) DYNJ59096C, UDI-DI: 10195327394042(each), 40195327394043(case), Lot Number: 24KBG881; 99) DYNJ56405C, UDI-DI: 10198459004520(each), 40198459004521(case), Lot Number: 24KBG893; 100) DYNJ46742B, UDI-DI: 10889942279272(each), 40889942279273(case), Lot Number: 24KBG956; 101) DYNJ63588B, UDI-DI: 10195327170677(each), 40195327170678(case), Lot Number: 24KBH020; 102) CDS982653K, UDI-DI: 10198459082030(each), 40198459082031(case), Lot Number: 24KBH139; 103) DYNJ61327C, UDI-DI: 10195327097103(each), 40195327097104(case), Lot Number: 24KBH337; 104) DYNJ81246, UDI-DI: 10195327097547(each), 40195327097548(case), Lot Number: 24KBH386; 105) DYNJ44990I, UDI-DI: 10198459156960(each), 40198459156961(case), Lot Number: 24KBH740; 106) DYNJ80274, UDI-DI: 10195327018283(each), 40195327018284(case), Lot Number: 24KBH796; 107) DYNJ58587B, UDI-DI: 10195327637576(each), 40195327637577(case), Lot Number: 24KBH881; 108) CDS982395D, UDI-DI: 10195327010386(each), 40195327010387(case), Lot Number: 24KBK715; 109) DYNJ14143J, UDI-DI: 10195327464806(each), 40195327464807(case), Lot Number: 24KBK901; 110) CDS985253M, UDI-DI: 10198459059889(each), 40198459059880(case), Lot Number: 24KBO929; 111) CDS983673J, UDI-DI: 10195327382261(each), 40195327382262(case), Lot Number: 24KBP694; 112) CDS981214A, UDI-DI: 10884389043158(each), 40884389043159(case), Lot Number: 24KBQ363; 113) CDS982421M, UDI-DI: 10195327210571(each), 40195327210572(case), Lot Number: 24KBQ711; 114) DYNJ909127F, UDI-DI: 10198459055423(each), 40198459055424(case), Lot Number: 24KBR465; 115) DYNJ901498B, UDI-DI: 10195327523985(each), 40195327523986(case), Lot Number: 24KBR477; 116) DYNJ903503C, UDI-DI: 10198459166112(each), 40198459166113(case), Lot Number: 24KBS227; 117) DYNJ904834G, UDI-DI: 10193489930382(each), 40193489930383(case), Lot Number: 24KBS233; 118) CDS982022T, UDI-DI: 10195327657581(each), 40195327657582(case), Lot Number: 24LBA370; 119) DYNJ908098A, UDI-DI: 10195327507251(each), 40195327507252(case), Lot Number: 24LBA991; 120) CDS760086R, UDI-DI: 10195327164775(each), 40195327164776(case), Lot Number: 24LBD961; 121) DYNJ903028M, UDI-DI: 10195327665203(each), 40195327665204(case), Lot Number: 24LBP333

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 14 of 34

Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S

Z-1599-2025
Recall number
Z-1599-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
530 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ59620A, UDI-DI: 10193489685367(each), 40193489685368(case), Lot Number: 24KBH321; 2) DYND150200S, UDI-DI: 10195327387884(each), 40195327387885(case), Lot Number: 24KBK308

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 15 of 34

Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Model Number: DYNJ66056; 6) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 7) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 8) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 9) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 10) FACE PACK, Model Number: DYNJ37316D; 11) PLASTIC PACK-LF, Model Number: DYNJ57440D; 12) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 13) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 14) SATELLITE MINOR PLASTIC PACK, Model Number: DYNJ63696; 15) FACIAL/EYE PACK, Model Number: DYNJ68328; 16) BREAST PACK, Model Number: DYNJ63753; 17) BREAST PACK, Model Number: DYNJ63753; 18) TUMMY PACK, Model Number: DYNJ64886A; 19) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 20) PLASTIC BREAST PACK, Model Number: DYNJ40620F; 21) PLASTIC ENT PACK, Model Number: DYNJ64712B; 22) PLASTIC SURGERY SERV-DR GARAZO, Model Number: DYNJ34199A; 23) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 24) OCULAR PLASTICS, Model Number: DYNJ55985D; 25) TUMMY PACK, Model Number: DYNJ64886A; 26) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 27) ZURI BREAST PACK, Model Number: DYNJ67772A; 28) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 29) TUMMY PACK, Model Number: DYNJ64886A; 30) OCCULAR PLASTIC PACK, Model Number: DYNJ35741D; 31) FACELIFT PACK, Model Number: DYNJ38907; 32) BREAST PACK, Model Number: DYNJ67882; 33) KDOP PLASTIC PACK, Model Number: DYNJ37142D

Z-1600-2025
Recall number
Z-1600-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
4094 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24IBH633; 2) DYNJ65109, UDI-DI: 10193489243826(each), 40193489243827(case), Lot Number: 24IBH739; 3) DYNJ34160D, UDI-DI: 10889942213542(each), 40889942213543(case), Lot Number: 24IBH802; 4) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24IBL195; 5) DYNJ66056, UDI-DI: 10193489318128(each), 40193489318129(case), Lot Number: 24IBR304; 6) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24JBL025; 7) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBM075; 8) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM318; 9) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM914; 10) DYNJ37316D, UDI-DI: 10193489672763(each), 40193489672764(case), Lot Number: 24JBT528; 11) DYNJ57440D, UDI-DI: 10193489238655(each), 40193489238656(case), Lot Number: 24JBT877; 12) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24JBV138; 13) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBV645; 14) DYNJ63696, UDI-DI: 10193489754704(each), 40193489754705(case), Lot Number: 24JBV846; 15) DYNJ68328, UDI-DI: 10193489823554(each), 40193489823555(case), Lot Number: 24JBW152; 16) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Number: 24JBW480; 17) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Number: 24JBX780; 18) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24JBX789; 19) DYNJ46737A, UDI-DI: 10889942116553(each), 40889942116554(case), Lot Number: 24KBA440; 20) DYNJ40620F, UDI-DI: 10195327631321(each), 40195327631322(case), Lot Number: 24KBB123; 21) DYNJ64712B, UDI-DI: 10198459166037(each), 40198459166038(case), Lot Number: 24KBB906; 22) DYNJ34199A, UDI-DI: 10884389380406(each), 40884389380407(case), Lot Number: 24KBC573; 23) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24KBC625; 24) DYNJ55985D, UDI-DI: 10193489288940(each), 40193489288941(case), Lot Number: 24KBC670; 25) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24KBC738; 26) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24KBC750; 27) DYNJ67772A, UDI-DI: 10195327209704(each), 40195327209705(case), Lot Number: 24KBC752; 28) DYNJ46737A, UDI-DI: 10889942116553(each), 40889942116554(case), Lot Number: 24KBE585; 29) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24KBF385; 30) DYNJ35741D, UDI-DI: 10889942108534(each), 40889942108535(case), Lot Number: 24KBF775; 31) DYNJ38907, UDI-DI: 10884389722176(each), 40884389722177(case), Lot Number: 24KBH241; 32) DYNJ67882, UDI-DI: 10193489449532(each), 40193489449533(case), Lot Number: 24KBH367; 33) DYNJ37142D, UDI-DI: 10195327467708(each), 40195327467709(case), Lot Number: 24KBI482

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 16 of 34

Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B

Z-1601-2025
Recall number
Z-1601-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ907733B, UDI-DI: 10195327671730(each), 40195327671731(case), Lot Number: 24KBJ999

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 17 of 34

Refer to RES

Z-1602-2025
Recall number
Z-1602-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
28127 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJHTLD02A, UDI-DI: 10193489303360(each), 40193489303361(case), Lot Number: 24IBE784; 2) DYNJ50017B, UDI-DI: 10889942851126(each), 40889942851127(case), Lot Number: 24IBE809; 3) DYNJ68242C, UDI-DI: 10198459091568(each), 40198459091569(case), Lot Number: 24IBF050; 4) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24IBF241; 5) DYNJ42691, UDI-DI: 10888277003507(each), 40888277003508(case), Lot Number: 24IBF320; 6) DYNJ43775C, UDI-DI: 10889942763191(each), 40889942763192(case), Lot Number: 24IBF620; 7) DYNJ54078A, UDI-DI: 10193489528633(each), 40193489528634(case), Lot Number: 24IBF640; 8) DYNJ39493B, UDI-DI: 10889942669998(each), 40889942669999(case), Lot Number: 24IBG032; 9) DYNJ0101397O, UDI-DI: 10195327661663(each), 40195327661664(case), Lot Number: 24IBG201; 10) DYNJ28408J, UDI-DI: 10195327279684(each), 40195327279685(case), Lot Number: 24IBG536; 11) DYNJ45997C, UDI-DI: 10889942684366(each), 40889942684367(case), Lot Number: 24IBG574; 12) DYNJ17504G, UDI-DI: 10195327224479(each), 40195327224470(case), Lot Number: 24IBG595; 13) DYNJ44532D, UDI-DI: 10195327463700(each), 40195327463701(case), Lot Number: 24IBG706; 14) DYNJ65996C, UDI-DI: 10195327621698(each), 40195327621699(case), Lot Number: 24IBG871; 15) DYNJ63703B, UDI-DI: 10193489883466(each), 40193489883467(case), Lot Number: 24IBH017; 16) DYNJ59621A, UDI-DI: 10193489685374(each), 40193489685375(case), Lot Number: 24IBH300; 17) DYNJ37733B, UDI-DI: 10889942775712(each), 40889942775713(case), Lot Number: 24IBH634; 18) DYKE1321B, UDI-DI: 10193489532890(each), 40193489532891(case), Lot Number: 24IBH701; 19) DYNJ24860G, UDI-DI: 10889942361618(each), 40889942361619(case), Lot Number: 24IBH843; 20) DYNJ81648, UDI-DI: 10195327130640(each), 40195327130641(case), Lot Number: 24IBH845; 21) DYNJ84619, UDI-DI: 10195327386252(each), 40195327386253(case), Lot Number: 24IBI031; 22) DYNJHTLD02A, UDI-DI: 10193489303360(each), 40193489303361(case), Lot Number: 24IBP627; 23) DYNJ69017, UDI-DI: 10193489878158(each), 40193489878159(case), Lot Number: 24IBP905; 24) DYNJ42913A, UDI-DI: 10195327080600(each), 40195327080601(case), Lot Number: 24IBQ345; 25) DYNJCHCY01A, UDI-DI: 10888277551664(each), 40888277551665(case), Lot Number: 24IBQ381; 26) DYNJ62614A, UDI-DI: 10193489445466(each), 40193489445467(case), Lot Number: 24IBQ618; 27) DYKL1252B, UDI-DI: 10889942440016(each), 40889942440017(case), Lot Number: 24IBQ716; 28) DYNJ54307A, UDI-DI: 10195327327378(each), 40195327327379(case), Lot Number: 24IBQ767; 29) DYNJ32910A, UDI-DI: 10195327279264(each), 40195327279265(case), Lot Number: 24IBR140; 30) DYNJ50747, UDI-DI: 10889942020577(each), 40889942020578(case), Lot Number: 24IBR572; 31) DYNJ83381A, UDI-DI: 10195327366094(each), 40195327366095(case), Lot Number: 24IBR622; 32) DYNJHS0525C, UDI-DI: 10195327599638(each), 40195327599639(case), Lot Number: 24IBR899; 33) DYNJ50581, UDI-DI: 10889942008445(each), 40889942008446(case), Lot Number: 24IBR902; 34) DYNJ59094, UDI-DI: 10889942933501(each), 40889942933502(case), Lot Number: 24IBS361; 35) DYNJ84440, UDI-DI: 10195327365127(each), 40195327365128(case), Lot Number: 24IBS371; 36) DYNJ51611A, UDI-DI: 10889942453849(each), 40889942453840(case), Lot Number: 24IBS387; 37) DYNJ52804A, UDI-DI: 10888277785328(each), 40888277785329(case), Lot Number: 24IBS836; 38) DYNJ60191A, UDI-DI: 10193489204742(each), 40193489204743(case), Lot Number: 24IBU433; 39) DYNJ65996C, UDI-DI: 10195327621698(each), 40195327621699(case), Lot Number: 24IBV594; 40) DYNJ44962K, UDI-DI: 10198459045462(each), 40198459045463(case), Lot Number: 24JBA280; 41) DYNJ57753, UDI-DI: 10889942774395(each), 40889942774396(case), Lot Number: 24JBA828; 42) DYNJ56508G, UDI-DI: 10193489734133(each), 40193489734134(case), Lot Number: 24JBA985; 43) DYNJ60802C, UDI-DI: 10195327404666(each), 40195327404667(case), Lot Number: 24JBF137; 44) DYNJ903254A, UDI-DI: 10889942632428(each), 40889942632429(case), Lot Number: 24JBK752; 45) DYNJ66251, UDI-DI: 10193489324778(each), 40193489324779(case), Lot Number: 24JBL345; 46) DYNJ52109, UDI-DI: 10889942239825(each), 40889942239826(case), Lot Number: 24JBL351; 47) DYNJ83154, UDI-DI: 10195327236847(each), 40195327236848(case), Lot Number: 24JBL827; 48) DYNJ40595A, UDI-DI: 10889942818648(each), 40889942818649(case), Lot Number: 24JBM390; 49) DYNJ48101C, UDI-DI: 10193489712520(each), 40193489712521(case), Lot Number: 24JBM496; 50) DYNJ62295B, UDI-DI: 10195327209933(each), 40195327209934(case), Lot Number: 24JBM500; 51) DYNJ33949G, UDI-DI: 10889942682515(each), 40889942682516(case), Lot Number: 24JBM602; 52) DYNJ34948C, UDI-DI: 10198459130076(each), 40198459130077(case), Lot Number: 24JBM855; 53) DYNJ39374B, UDI-DI: 10889942670871(each), 40889942670872(case), Lot Number: 24JBM858; 54) DYNJ41860B, UDI-DI: 10193489662634(each), 40193489662635(case), Lot Number: 24JBM890; 55) DYNJ66255, UDI-DI: 10193489324983(each), 40193489324984(case), Lot Number: 24JBM944; 56) DYNJ62348C, UDI-DI: 10195327538569(each), 40195327538560(case), Lot Number: 24JBN288; 57) DYNJ52891A, UDI-DI: 10889942819805(each), 40889942819806(case), Lot Number: 24JBN389; 58) DYNJ84784A, UDI-DI: 10195327447922(each), 40195327447923(case), Lot Number: 24JBN412; 59) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24JBN423; 60) DYNJ37145F, UDI-DI: 10195327467692(each), 40195327467693(case), Lot Number: 24JBN425; 61) DYNJ85241, UDI-DI: 10195327482657(each), 40195327482658(case), Lot Number: 24JBO099; 62) DYNJ52921B, UDI-DI: 10889942739240(each), 40889942739241(case), Lot Number: 24JBO261; 63) DYNJ82242, UDI-DI: 10195327181420(each), 40195327181421(case), Lot Number: 24JBO566; 64) CDS984266J, UDI-DI: 10193489862386(each), 40193489862387(case), Lot Number: 24JBO721; 65) DYNJ24478G, UDI-DI: 10193489866599(each), 40193489866590(case), Lot Number: 24JBR846; 66) DYNJ54741A, UDI-DI: 10889942921164(each), 40889942921165(case), Lot Number: 24JBT042; 67) DYNJ83931, UDI-DI: 10195327315351(each), 40195327315352(case), Lot Number: 24JBT083; 68) DYNJ57965B, UDI-DI: 10195327390037(each), 40195327390038(case), Lot Number: 24JBT485; 69) DYNJ67974, UDI-DI: 10193489462319(each), 40193489462310(case), Lot Number: 24JBT495; 70) DYNJ62128A, UDI-DI: 10193489449877(each), 40193489449878(case), Lot Number: 24JBT723; 71) DYNJ81969C, UDI-DI: 10198459003592(each), 40198459003593(case), Lot Number: 24JBT793; 72) DYNJ69017, UDI-DI: 10193489878158(each), 40193489878159(case), Lot Number: 24JBT855; 73) DYNJ48102C, UDI-DI: 10193489712537(each), 40193489712538(case), Lot Number: 24JBT937; 74) DYNJ43790, UDI-DI: 10888277068711(each), 40888277068712(case), Lot Number: 24JBT972; 75) SYNJ10266A, UDI-DI: 10193489785111(each), 40193489785112(case), Lot Number: 24JBU049; 76) DYNJ50747, UDI-DI: 10889942020577(each), 40889942020578(case), Lot Number: 24JBU066; 77) DYNJ44745B, UDI-DI: 10193489225693(each), 40193489225694(case), Lot Number: 24JBU107; 78) DYNJ49508A, UDI-DI: 10193489704013(each), 40193489704014(case), Lot Number: 24JBU167; 79) DYNJ49255B, UDI-DI: 10198459165023(each), 40198459165024(case), Lot Number: 24JBU462; 80) DYNJ39064, UDI-DI: 10884389736838(each), 40884389736839(case), Lot Number: 24JBU474; 81) DYNJ65869, UDI-DI: 10193489304039(each), 40193489304030(case), Lot Number: 24JBV140; 82) DYNJ46786G, UDI-DI: 10193489204353(each), 40193489204354(case), Lot Number: 24JBV421; 83) DYNJ35732D, UDI-DI: 10889942140701(each), 40889942140702(case), Lot Number: 24JBV518; 84) DYNJ68390C, UDI-DI: 10195327341671(each), 40195327341672(case), Lot Number: 24JBV597; 85) DYNJ48474G, UDI-DI: 10888277767867(each), 40888277767868(case), Lot Number: 24JBV613; 86) DYNJ54609C, UDI-DI: 10198459046452(each), 40198459046453(case), Lot Number: 24JBV668; 87) DYNJ63703B, UDI-DI: 10193489883466(each), 40193489883467(case), Lot Number: 24JBV847; 88) DYNJ84831A, UDI-DI: 10198459136962(each), 40198459136963(case), Lot Number: 24JBV896; 89) DYNJ61473, UDI-DI: 10193489572315(each), 40193489572316(case), Lot Number: 24JBW127; 90) DYNJ61467, UDI-DI: 10193489572261(each), 40193489572262(case), Lot Number: 24JBW164; 91) DYNJ59370B, UDI-DI: 10198459165801(each), 40198459165802(case), Lot Number: 24JBW172; 92) DYNJ36096F, UDI-DI: 10195327654085(each), 40195327654086(case), Lot Number: 24JBW181; 93) DYNJ37318F, UDI-DI: 10193489672756(each), 40193489672757(case), Lot Number: 24JBW188; 94) DYNJ55425B, UDI-DI: 10193489297416(each), 40193489297417(case), Lot Number: 24JBW462; 95) DYNJ51016, UDI-DI: 10889942111213(each), 40889942111214(case), Lot Number: 24JBW498; 96) DYNJ19845K, UDI-DI: 10888277851030(each), 40888277851031(case), Lot Number: 24JBX126; 97) PHS419284011D, UDI-DI: 10198459132124(each), 40198459132125(case), Lot Number: 24JBX226; 98) DYKL1252B, UDI-DI: 10889942440016(each), 40889942440017(case), Lot Number: 24JBX632; 99) DYNJ45044D, UDI-DI: 10193489235500(each), 40193489235501(case), Lot Number: 24JBX706; 100) DYNJ45997C, UDI-DI: 10889942684366(each), 40889942684367(case), Lot Number: 24JBX711; 101) DYNJ57753, UDI-DI: 10889942774395(each), 40889942774396(case), Lot Number: 24JBX748; 102) DYNJ58401A, UDI-DI: 10889942969586(each), 40889942969587(case), Lot Number: 24JBX751; 103) DYNJ55206A, UDI-DI: 10193489727067(each), 40193489727068(case), Lot Number: 24JBX991; 104) DYNJ68761A, UDI-DI: 10198459031847(each), 40198459031848(case), Lot Number: 24JBY188; 105) DYNJ44858J, UDI-DI: 10195327127336(each), 40195327127337(case), Lot Number: 24JBY279; 106) DYNJ64353A, UDI-DI: 10193489285871(each), 40193489285872(case), Lot Number: 24KBA223; 107) DYNJ44037D, UDI-DI: 10195327038748(each), 40195327038749(case), Lot Number: 24KBA571; 108) DYNJ61350, UDI-DI: 10193489560992(each), 40193489560993(case), Lot Number: 24KBA573; 109) DYNJ0373855R, UDI-DI: 10198459062193(each), 40198459062194(case), Lot Number: 24KBA650; 110) DYNJ57039B, UDI-DI: 10193489353433(each), 40193489353434(case), Lot Number: 24KBA692; 111) DYNJ30550F, UDI-DI: 10198459130946(each), 40198459130947(case), Lot Number: 24KBB141; 112) DYNJ36951A, UDI-DI: 10884389666630(each), 40884389666631(case), Lot Number: 24KBB214; 113) DYNJ56508G, UDI-DI: 10193489734133(each), 40193489734134(case), Lot Number: 24KBB217; 114) DYNJ30550F, UDI-DI: 10198459130946(each), 40198459130947(case), Lot Number: 24KBB400; 115) DYNJ41724, UDI-DI: 10888277021488(each), 40888277021489(case), Lot Number: 24KBB417; 116) DYNJ60250A, UDI-DI: 10198459015274(each), 40198459015275(case), Lot Number: 24KBB762; 117) DYNJ56862D, UDI-DI: 10195327642969(each), 40195327642960(case), Lot Number: 24KBB799; 118) DYNJ65800, UDI-DI: 10193489291278(each), 40193489291279(case), Lot Number: 24KBB811; 119) DYNJ61287, UDI-DI: 10193489554854(each), 40193489554855(case), Lot Number: 24KBC474; 120) DYNJ69943C, UDI-DI: 10198459057359(each), 40198459057350(case), Lot Number: 24KBC517; 121) DYNJ16105F, UDI-DI: 10889942364169(each), 40889942364160(case), Lot Number: 24KBC556; 122) DYNJ17504G, UDI-DI: 10195327224479(each), 40195327224470(case), Lot Number: 24KBC559; 123) DYNJ37032F, UDI-DI: 10193489637175(each), 40193489637176(case), Lot Number: 24KBC579; 124) DYNJ39496A, UDI-DI: 10889942670345(each), 40889942670346(case), Lot Number: 24KBC591; 125) DYNJ60396, UDI-DI: 10193489500301(each), 40193489500302(case), Lot Number: 24KBC689; 126) DYNJ61364A, UDI-DI: 10193489722116(each), 40193489722117(case), Lot Number: 24KBC706; 127) DYNJ64353A, UDI-DI: 10193489285871(each), 40193489285872(case), Lot Number: 24KBC729; 128) DYNJ67867C, UDI-DI: 10198459158490(each), 40198459158491(case), Lot Number: 24KBC757; 129) DYNJ81788, UDI-DI: 10195327143114(each), 40195327143115(case), Lot Number: 24KBC802; 130) DYNJ86504, UDI-DI: 10195327643690(each), 40195327643691(case), Lot Number: 24KBC868; 131) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24KBC906; 132) DYNJ43428, UDI-DI: 10888277051263(each), 40888277051264(case), Lot Number: 24KBD224; 133) DYNJ41941D, UDI-DI: 10193489753707(each), 40193489753708(case), Lot Number: 24KBD843; 134) DYNJ44028A, UDI-DI: 10889942135691(each), 40889942135692(case), Lot Number: 24KBD852; 135) DYNJ51865A, UDI-DI: 10889942322633(each), 40889942322634(case), Lot Number: 24KBD881; 136) DYNJ53122B, UDI-DI: 10193489321227(each), 40193489321228(case), Lot Number: 24KBD891; 137) DYNJ54064B, UDI-DI: 10198459155413(each), 40198459155414(case), Lot Number: 24KBD896; 138) DYNJ58341, UDI-DI: 10889942842438(each), 40889942842439(case), Lot Number: 24KBE274; 139) DYNJ48017F, UDI-DI: 10198459129049(each), 40198459129040(case), Lot Number: 24KBE389; 140) DYNJ56857G, UDI-DI: 10195327614669(each), 40195327614660(case), Lot Number: 24KBE656; 141) DYNJ60279C, UDI-DI: 10195327441760(each), 40195327441761(case), Lot Number: 24KBF085; 142) DYNJ33451L, UDI-DI: 10198459169687(each), 40198459169688(case), Lot Number: 24KBF135; 143) DYNJ32910A, UDI-DI: 10195327279264(each), 40195327279265(case), Lot Number: 24KBF321; 144) DYNJ40110, UDI-DI: 10884389837849(each), 40884389837840(case), Lot Number: 24KBF330; 145) DYNJ54033, UDI-DI: 10889942457588(each), 40889942457589(case), Lot Number: 24KBF361; 146) DYNJ62502, UDI-DI: 10193489664874(each), 40193489664875(case), Lot Number: 24KBG152; 147) DYNJ15962I, UDI-DI: 10889942364138(each), 40889942364139(case), Lot Number: 24KBG286; 148) DYNJ51162, UDI-DI: 10889942141821(each), 40889942141822(case), Lot Number: 24KBG849; 149) DYNJ23098K, UDI-DI: 10193489213331(each), 40193489213332(case), Lot Number: 24KBG919; 150) DYNJ54307A, UDI-DI: 10195327327378(each), 40195327327379(case), Lot Number: 24KBG970; 151) DYNDH1606, UDI-DI: 10193489844771(each), 40193489844772(case), Lot Number: 24KBH207; 152) DYNJ40391, UDI-DI: 10884389864531(each), 40884389864532(case), Lot Number: 24KBH247; 153) DYNJ54033, UDI-DI: 10889942457588(each), 40889942457589(case), Lot Number: 24KBH291; 154) DYNJ58419B, UDI-DI: 10193489915938(each), 40193489915939(case), Lot Number: 24KBH312; 155) DYNJ69967B, UDI-DI: 10198459070532(each), 40198459070533(case), Lot Number: 24KBH377; 156) DYNJ68519A, UDI-DI: 10193489916041(each), 40193489916042(case), Lot Number: 24KBH523; 157) DYNJ0858275B, UDI-DI: 10889942137251(each), 40889942137252(case), Lot Number: 24KBH791; 158) DYNJ52804A, UDI-DI: 10888277785328(each), 40888277785329(case), Lot Number: 24KBH845; 159) DYNJ85345A, UDI-DI: 10198459111549(each), 40198459111540(case), Lot Number: 24KBI150; 160) DYNJ55866C, UDI-DI: 10198459126093(each), 40198459126094(case), Lot Number: 24KBK546; 161) DYNJ81892D, UDI-DI: 10198459048104(each), 40198459048105(case), Lot Number: 24KBM589; 162) DYNJ909278A, UDI-DI: 10195327605247(each), 40195327605248(case), Lot Number: 24KBP718; 163) DYNJ903255A, UDI-DI: 10889942632435(each), 40889942632436(case), Lot Number: 24KBQ385; 164) CDS980470D, UDI-DI: 10889942965045(each), 40889942965046(case), Lot Number: 24KBQ708; 165) CDS982696K, UDI-DI: 10193489441406(each), 40193489441407(case), Lot Number: 24KBR961; 166) DYNJ907550B, UDI-DI: 10195327076320(each), 40195327076321(case), Lot Number: 24LBD358; 167) CDS840343K, UDI-DI: 10888277865693(each), 40888277865694(case), Lot Number: 24LBD743; 168) CDS983099K, UDI-DI: 10198459020377(each), 40198459020378(case), Lot Number: 24LBE132; 169) DYNJ904853A, UDI-DI: 10193489630978(each), 40193489630979(case), Lot Number: 24LBJ828; 170) DYNJ901896C, UDI-DI: 10193489553789(each), 40193489553780(case), Lot Number: 24LBL495

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 18 of 34

Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590

Z-1603-2025
Recall number
Z-1603-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) MNS12590, UDI-DI: 10653160342052(each), 40653160342053(case), Lot Number: 24IBH166

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 19 of 34

Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422

Z-1604-2025
Recall number
Z-1604-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
84 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ88422, UDI-DI: 10198459157042(each), 40198459157043(case), Lot Number: 24KBD426

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 20 of 34

Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

Z-1605-2025
Recall number
Z-1605-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) SUT15830A, UDI-DI: 10653160996750(each), 40653160996751(case), Lot Number: 24IBR642

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 21 of 34

Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270

Z-1606-2025
Recall number
Z-1606-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) MNS6270, UDI-DI: 10653160220893(each), 40653160220894(case), Lot Number: 24KBD496

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 22 of 34

Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

Z-1607-2025
Recall number
Z-1607-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJCD0339, UDI-DI: 10195327483753(each), 40195327483754(case), Lot Number: 24KBK055

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 23 of 34

Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239

Z-1608-2025
Recall number
Z-1608-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJCD0239, UDI-DI: 10889942245901(each), 40889942245902(case), Lot Number: 24IBR482

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 24 of 34

Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C

Z-1609-2025
Recall number
Z-1609-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24KBK455

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 25 of 34

Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model Number: DYNJ53032C

Z-1610-2025
Recall number
Z-1610-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
354 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ41856C, UDI-DI: 10195327429010(each), 40195327429011(case), Lot Number: 24JBM711; 2) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24JBN788; 3) DYNJ50629M, UDI-DI: 10198459146985(each), 40198459146986(case), Lot Number: 24JBW674; 4) DYNJ40040C, UDI-DI: 10889942683970(each), 40889942683971(case), Lot Number: 24KBC507; 5) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24KBC655

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 26 of 34

Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5) PACK VAGINAL DELIVERY, Model Number: HM190A; 6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B; 7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B; 9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C; 10) VAGINAL DEL PK, Model Number: DYNJ65689; 11) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 12) L&D PACK-LF, Model Number: DYNJ0731657M; 13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B; 14) VAD ACCESS, Model Number: DYNJ24276C; 15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304; 16) VAGINAL DELIVERY CDS, Model Number: CDS982762I; 17) VAGINAL DELIVERY, Model Number: DYNJ903796C; 18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 20) BR L&D PACK, Model Number: DYNJ47625B; 21) OB PACK, Model Number: DYNJ03387B; 22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B; 25) L AND D PACK, Model Number: DYNJHTLD03A; 26) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 27) VAG DELIVERY PACK, Model Number: DYNJ34949; 28) OB PACK, Model Number: DYNJ55835B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 30) OB PACK, Model Number: DYNJ83115; 31) VAGINAL DEL PK, Model Number: DYNJ65689; 32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B; 33) LABOR & DELIVERY PACK, Model Number: DYNJ69433; 34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250; 35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G; 36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C; 37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329; 38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D; 39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F; 40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A; 41) VAGINAL DELIVERY, Model Number: DYNJ903796C; 42) DELIVERY PACK, Model Number: DYNJ69964; 43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D; 44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A; 45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K; 46) O.B. PACK-LF, Model Number: DYNJ07520J; 47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 49) CUH VAGINAL-LF, Model Number: DYNJC9242C; 50) VAGINAL DELIVERY, Model Number: DYNJ903796C; 51) VAGINAL DELIVERY, Model Number: DYNJ907958; 52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A; 53) CUH VAGINAL-LF, Model Number: DYNJC9242C; 54) VAGINAL DELIVERY, Model Number: DYNJ903796C; 55) VAGINAL DELIVERY, Model Number: DYNJ907958

Z-1611-2025
Recall number
Z-1611-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
21935 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ26971L, UDI-DI: 10198459087158(each), 40198459087159(case), Lot Number: 24IBD872; 2) DYNJ0378319P, UDI-DI: 10198459105722(each), 40198459105723(case), Lot Number: 24IBF374; 3) DYNJ64017B, UDI-DI: 10195327550325(each), 40195327550326(case), Lot Number: 24IBG070; 4) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24IBH288; 5) HM190A, UDI-DI: 10195327305161(each), 40195327305162(case), Lot Number: 24IBH818; 6) SYNJ10248B, UDI-DI: 10193489373387(each), 40193489373388(case), Lot Number: 24IBH820; 7) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24IBH988; 8) DYNJ49542B, UDI-DI: 10195327388072(each), 40195327388073(case), Lot Number: 24IBR452; 9) DYNJ37124C, UDI-DI: 10195327416195(each), 40195327416196(case), Lot Number: 24IBR491; 10) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24IBR570; 11) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24IBR650; 12) DYNJ0731657M, UDI-DI: 10195327697020(each), 40195327697021(case), Lot Number: 24IBR661; 13) DYNJ43604B, UDI-DI: 10193489997521(each), 40193489997522(case), Lot Number: 24IBR707; 14) DYNJ24276C, UDI-DI: 10884389431184(each), 40884389431185(case), Lot Number: 24IBS408; 15) DYNJ80304, UDI-DI: 10195327022532(each), 40195327022533(case), Lot Number: 24IBS686; 16) CDS982762I, UDI-DI: 10193489942095(each), 40193489942096(case), Lot Number: 24JBB609; 17) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24JBE762; 18) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM324; 19) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM600; 20) DYNJ47625B, UDI-DI: 10889942182589(each), 40889942182580(case), Lot Number: 24JBN320; 21) DYNJ03387B, UDI-DI: 10195327191092(each), 40195327191093(case), Lot Number: 24JBO026; 22) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24JBR630; 23) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 24) DYNJ23158B, UDI-DI: 10195327473891(each), 40195327473892(case), Lot Number: 24JBU459; 25) DYNJHTLD03A, UDI-DI: 10193489303353(each), 40193489303354(case), Lot Number: 24JBU555; 26) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24JBV052; 27) DYNJ34949, UDI-DI: 10884389403358(each), 40884389403359(case), Lot Number: 24JBV802; 28) DYNJ55835B, UDI-DI: 10195327319946(each), 40195327319947(case), Lot Number: 24JBV820; 29) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24JBV866; 30) DYNJ83115, UDI-DI: 10195327232979(each), 40195327232970(case), Lot Number: 24JBV884; 31) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24JBW792; 32) DYNJ64828B, UDI-DI: 10198459140280(each), 40198459140281(case), Lot Number: 24JBX788; 33) DYNJ69433, UDI-DI: 10193489940985(each), 40193489940986(case), Lot Number: 24JBX797; 34) DYNJS8250, UDI-DI: 10884389349298(each), 40884389349299(case), Lot Number: 24KBA046; 35) DYNJ24514G, UDI-DI: 10193489893656(each), 40193489893657(case), Lot Number: 24KBA388; 36) DYNJ63270C, UDI-DI: 10193489862614(each), 40193489862615(case), Lot Number: 24KBB101; 37) DYNJ80329, UDI-DI: 10195327027193(each), 40195327027194(case), Lot Number: 24KBB586; 38) DYNJ40009D, UDI-DI: 10195327362362(each), 40195327362363(case), Lot Number: 24KBC597; 39) DYNJ45589F, UDI-DI: 10198459125904(each), 40198459125905(case), Lot Number: 24KBC628; 40) DYNJ82620A, UDI-DI: 10198459150081(each), 40198459150082(case), Lot Number: 24KBC810; 41) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBD009; 42) DYNJ69964, UDI-DI: 10195327000660(each), 40195327000661(case), Lot Number: 24KBE397; 43) DYNJ34315D, UDI-DI: 10198459168369(each), 40198459168360(case), Lot Number: 24KBF136; 44) DYNJ57668A, UDI-DI: 10193489795622(each), 40193489795623(case), Lot Number: 24KBG150; 45) DYNJ35608K, UDI-DI: 10195327099022(each), 40195327099023(case), Lot Number: 24KBG823; 46) DYNJ07520J, UDI-DI: 10198459015533(each), 40198459015534(case), Lot Number: 24KBG847; 47) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24KBG879; 48) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24KBH870; 49) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24KBL933; 50) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBN086; 51) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 24KBQ773; 52) DYNJ908581A, UDI-DI: 10195327594664(each), 40195327594665(case), Lot Number: 24KBU702; 53) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24LBK538; 54) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24LBO942; 55) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 25ABA840

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 27 of 34

Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

Z-1612-2025
Recall number
Z-1612-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ80807B, UDI-DI: 10195327415624(each), 40195327415625(case), Lot Number: 24IBH993

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 28 of 34

Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE LITHOMIE MINEURE-LF, Model Number: DYNJ47552C; 6) CH D&C PACK, Model Number: DYNJ67945; 7) LAP GYN PACK-LF, Model Number: DYNJ25892K; 8) GYN LAPAROSCOPY PACK BJC-LF, Model Number: DYNJ41670B; 9) OPP GYN VAGINAL PACK, Model Number: DYNJ67227; 10) GYNE MINOR LAPAROSCOPY GRH-LF, Model Number: DYNJ41790F; 11) GYNE - LITHOTOMY MINOR PACK-LF, Model Number: DYNJ49251C; 12) STANDARD D&C, Model Number: DYNJ69733; 13) PERI GYN PACK, Model Number: DYNJ24338I; 14) GYN LAPAROSCOPY CDS, Model Number: CDS982727L; 15) ROBOTICS, Model Number: DYNJ908712B

Z-1613-2025
Recall number
Z-1613-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
706 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ69733, UDI-DI: 10193489974089(each), 40193489974080(case), Lot Number: 24IBE079; 2) DYNJ39904A, UDI-DI: 10888277801905(each), 40888277801906(case), Lot Number: 24IBF466; 3) DYNJ64651A, UDI-DI: 10195327057381(each), 40195327057382(case), Lot Number: 24IBS312; 4) DYNJ49250F, UDI-DI: 10195327680145(each), 40195327680146(case), Lot Number: 24JBM609; 5) DYNJ47552C, UDI-DI: 10193489845594(each), 40193489845595(case), Lot Number: 24JBN271; 6) DYNJ67945, UDI-DI: 10193489458695(each), 40193489458696(case), Lot Number: 24JBU691; 7) DYNJ25892K, UDI-DI: 10193489905434(each), 40193489905435(case), Lot Number: 24JBV586; 8) DYNJ41670B, UDI-DI: 10198459124228(each), 40198459124229(case), Lot Number: 24KBA786; 9) DYNJ67227, UDI-DI: 10193489391640(each), 40193489391641(case), Lot Number: 24KBC196; 10) DYNJ41790F, UDI-DI: 10195327547134(each), 40195327547135(case), Lot Number: 24KBC471; 11) DYNJ49251C, UDI-DI: 10195327679644(each), 40195327679645(case), Lot Number: 24KBG007; 12) DYNJ69733, UDI-DI: 10193489974089(each), 40193489974080(case), Lot Number: 24KBH831; 13) DYNJ24338I, UDI-DI: 10193489326161(each), 40193489326162(case), Lot Number: 24KBH862; 14) CDS982727L, UDI-DI: 10195327258023(each), 40195327258024(case), Lot Number: 24KBU700; 15) DYNJ908712B, UDI-DI: 10198459187216(each), 40198459187217(case), Lot Number: 24LBF830

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 29 of 34

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

Z-1614-2025
Recall number
Z-1614-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
1098 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM309; 3) OBK387M, UDI-DI: 10889942686810(each), 40889942686811(case), Lot Number: 24JBM385; 4) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM576; 5) DYNJ40573A, UDI-DI: 10888277988514(each), 40888277988515(case), Lot Number: 24JBM871; 6) CDS983998C, UDI-DI: 10193489776713(each), 40193489776714(case), Lot Number: 24JBS915; 7) DYNJ64300A, UDI-DI: 10193489852370(each), 40193489852371(case), Lot Number: 24JBU461; 8) DYNJ55205, UDI-DI: 10889942532803(each), 40889942532804(case), Lot Number: 24JBV449; 9) DYNJ56550, UDI-DI: 10889942671779(each), 40889942671770(case), Lot Number: 24JBV561; 10) DYNJ83507, UDI-DI: 10195327273071(each), 40195327273072(case), Lot Number: 24JBX835; 11) DYNJ83248, UDI-DI: 10195327248383(each), 40195327248384(case), Lot Number: 24KBF051; 12) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24KBG874

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 30 of 34

Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6) HYSTEROSCOPY PACK, Model Number: DYNJ56417C; 7) HYSTEROSCOPY PACK CKHA-LF, Model Number: DYNJ51956B; 8) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B

Z-1615-2025
Recall number
Z-1615-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
671 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ80786, UDI-DI: 10195327079451(each), 40195327079452(case), Lot Number: 24IBH305; 2) DYNJ21937J, UDI-DI: 10195327694876(each), 40195327694877(case), Lot Number: 24JBN378; 3) DYNJ41949B, UDI-DI: 10195327128937(each), 40195327128938(case), Lot Number: 24JBT902; 4) DYNJ21824R, UDI-DI: 10195327107758(each), 40195327107759(case), Lot Number: 24JBU465; 5) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 24JBV636; 6) DYNJ56417C, UDI-DI: 10195327468804(each), 40195327468805(case), Lot Number: 24KBB818; 7) DYNJ51956B, UDI-DI: 10889942599394(each), 40889942599395(case), Lot Number: 24KBC171; 8) DYNJ41949B, UDI-DI: 10195327128937(each), 40195327128938(case), Lot Number: 24KBC614

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 31 of 34

Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ50656B; 11) TRANSVAGINAL PACK, Model Number: DYNJ36599; 12) OB PACK, Model Number: DYNJ25915G; 13) PERI GYN-LF, Model Number: DYNJS3040; 14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A; 15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A; 16) OB PACK, Model Number: DYNJ64571; 17) WMC D & C PACK-LF, Model Number: DYNJ50656B; 18) D & C PACK-LF, Model Number: DYNJT2535G; 19) OB PACK, Model Number: DYNJ44522B; 20) OB PACK-LF, Model Number: DYNJ26121G; 21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C

Z-1616-2025
Recall number
Z-1616-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
2,531 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ68673, UDI-DI: 10193489839951(each), 40193489839952(case), Lot Number: 24IBG873; 2) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24IBG957; 3) DYNJ24159C, UDI-DI: 10198459032394(each), 40198459032395(case), Lot Number: 24IBL229; 4) DYNJ54484A, UDI-DI: 10193489813074(each), 40193489813075(case), Lot Number: 24IBS805; 5) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBL655; 6) DYNJ900422F, UDI-DI: 10195327658373(each), 40195327658374(case), Lot Number: 24JBM234; 7) CDS985201A, UDI-DI: 10889942942312(each), 40889942942313(case), Lot Number: 24JBN479; 8) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24JBN645; 9) DYNJ47616B, UDI-DI: 10193489731040(each), 40193489731041(case), Lot Number: 24JBT461; 10) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24JBT906; 11) DYNJ36599, UDI-DI: 10884389554142(each), 40884389554143(case), Lot Number: 24JBW173; 12) DYNJ25915G, UDI-DI: 10193489718942(each), 40193489718943(case), Lot Number: 24JBW203; 13) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBW545; 14) DYNJ0989660A, UDI-DI: 10889942136131(each), 40889942136132(case), Lot Number: 24JBX677; 15) DYNJ64226A, UDI-DI: 10195327135430(each), 40195327135431(case), Lot Number: 24KBC728; 16) DYNJ64571, UDI-DI: 10193489208986(each), 40193489208987(case), Lot Number: 24KBD692; 17) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24KBF096; 18) DYNJT2535G, UDI-DI: 10195327548506(each), 40195327548507(case), Lot Number: 24KBG398; 19) DYNJ44522B, UDI-DI: 10193489691511(each), 40193489691512(case), Lot Number: 24KBG967; 20) DYNJ26121G, UDI-DI: 10889942225248(each), 40889942225249(case), Lot Number: 24KBG978; 21) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24KBS436; 22) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBF208; 23) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBR809; 24) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 25ABF622

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 32 of 34

Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number: DYNJ44748I; 7) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 8) CHOG MINOR OPHTHALMIC PACK, Model Number: SYNJ10271B; 9) LIFESPAN VITRECTOMY PACK, Model Number: DYNJ80082; 10) DR KEYS EYE PACK 2, Model Number: DYNJ48256M; 11) VITRECTOMY PACK, Model Number: DYNJ55508B; 12) EYE PACK, Model Number: DYNJ63952A; 13) VITRECTOMY, Model Number: DYNJ67309C; 14) CATARACT PACK-MARY IMMACUL-LF, Model Number: DYNJ24516F; 15) DR FLOOD EYE PACK, Model Number: DYNJ57258G; 16) BLEPH PACK, Model Number: DYNJ67875; 17) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) OPHTHALMOLOGY PACK, Model Number: SYNJ10259A; 20) PLASTIC EYE, Model Number: DYNJ45667C; 21) BASIC EYE PACK, Model Number: DYNJ81548B; 22) WMC CATARACT PACK-LF, Model Number: DYNJ50653F; 23) BASIC CATARACT, Model Number: DYNJ41097A; 24) PK EYE, Model Number: DYNJ60631B; 25) EYE PLASTIC SURGERY PACK, Model Number: DYNJ44061; 26) CATARACT, Model Number: DYNJ44544F; 27) CATARACT PACK, Model Number: DYNJ49515D; 28) CATARACT PACK, Model Number: DYNJ35438F; 29) OPHTHALMIC PLASTIC PACK, Model Number: DYNJ55208A; 30) CATARACT PACK, Model Number: DYNJ81534B; 31) CATARACT PACK, Model Number: DYNJ49515D

Z-1617-2025
Recall number
Z-1617-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
3909 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24IBF244; 2) DYNJ60631B, UDI-DI: 10193489994421(each), 40193489994422(case), Lot Number: 24IBG352; 3) DYNJ80316A, UDI-DI: 10195327245221(each), 40195327245222(case), Lot Number: 24IBG593; 4) DYNJ63707C, UDI-DI: 10193489883503(each), 40193489883504(case), Lot Number: 24IBH027; 5) DYNJ85284, UDI-DI: 10195327486457(each), 40195327486458(case), Lot Number: 24IBH266; 6) DYNJ44748I, UDI-DI: 10193489273458(each), 40193489273459(case), Lot Number: 24IBH805; 7) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 24IBS294; 8) SYNJ10271B, UDI-DI: 10193489457209(each), 40193489457200(case), Lot Number: 24IBS393; 9) DYNJ80082, UDI-DI: 10195327012007(each), 40195327012008(case), Lot Number: 24IBS417; 10) DYNJ48256M, UDI-DI: 10195327466176(each), 40195327466177(case), Lot Number: 24JBJ668; 11) DYNJ55508B, UDI-DI: 10195327266912(each), 40195327266913(case), Lot Number: 24JBN908; 12) DYNJ63952A, UDI-DI: 10193489393958(each), 40193489393959(case), Lot Number: 24JBT060; 13) DYNJ67309C, UDI-DI: 10195327668990(each), 40195327668991(case), Lot Number: 24JBT766; 14) DYNJ24516F, UDI-DI: 10195327278458(each), 40195327278459(case), Lot Number: 24JBU088; 15) DYNJ57258G, UDI-DI: 10195327491123(each), 40195327491124(case), Lot Number: 24JBV026; 16) DYNJ67875, UDI-DI: 10193489448825(each), 40193489448826(case), Lot Number: 24JBW137; 17) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 24JBX679; 18) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 19) SYNJ10259A, UDI-DI: 10193489786873(each), 40193489786874(case), Lot Number: 24KBB063; 20) DYNJ45667C, UDI-DI: 10193489991062(each), 40193489991063(case), Lot Number: 24KBC142; 21) DYNJ81548B, UDI-DI: 10198459100277(each), 40198459100278(case), Lot Number: 24KBC156; 22) DYNJ50653F, UDI-DI: 10195327653149(each), 40195327653140(case), Lot Number: 24KBD242; 23) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24KBD377; 24) DYNJ60631B, UDI-DI: 10193489994421(each), 40193489994422(case), Lot Number: 24KBF041; 25) DYNJ44061, UDI-DI: 10888277081994(each), 40888277081995(case), Lot Number: 24KBF076; 26) DYNJ44544F, UDI-DI: 10198459122804(each), 40198459122805(case), Lot Number: 24KBF265; 27) DYNJ49515D, UDI-DI: 10193489508024(each), 40193489508025(case), Lot Number: 24KBH120; 28) DYNJ35438F, UDI-DI: 10193489612028(each), 40193489612029(case), Lot Number: 24KBH238; 29) DYNJ55208A, UDI-DI: 10193489967593(each), 40193489967594(case), Lot Number: 24KBH297; 30) DYNJ81534B, UDI-DI: 10198459082917(each), 40198459082918(case), Lot Number: 24KBH549; 31) DYNJ49515D, UDI-DI: 10193489508024(each), 40193489508025(case), Lot Number: 24KBI136

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 33 of 34

Refer to RES

Z-1618-2025
Recall number
Z-1618-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
11889 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ61594, UDI-DI: 10193489586121(each), 40193489586122(case), Lot Number: 24IBF062; 2) DYNJ31798D, UDI-DI: 10195327609078(each), 40195327609079(case), Lot Number: 24IBF219; 3) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBF751; 4) DYNJ49386A, UDI-DI: 10889942292882(each), 40889942292883(case), Lot Number: 24IBF768; 5) DYNJ51781G, UDI-DI: 10198459045974(each), 40198459045975(case), Lot Number: 24IBG614; 6) DYNJ54474C, UDI-DI: 10195327698560(each), 40195327698561(case), Lot Number: 24IBG988; 7) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBH023; 8) DYNJ65348, UDI-DI: 10193489268881(each), 40193489268882(case), Lot Number: 24IBH081; 9) DYNJ37322I, UDI-DI: 10193489961553(each), 40193489961554(case), Lot Number: 24IBH579; 10) DYNJ69926A, UDI-DI: 10195327153601(each), 40195327153602(case), Lot Number: 24IBH589; 11) DYNJ39903, UDI-DI: 10884389842072(each), 40884389842073(case), Lot Number: 24IBH647; 12) DYNJ47816B, UDI-DI: 10193489370256(each), 40193489370257(case), Lot Number: 24IBH806; 13) SYNJ10253B, UDI-DI: 10193489373592(each), 40193489373593(case), Lot Number: 24IBH821; 14) DYNJ31169C, UDI-DI: 10889942373468(each), 40889942373469(case), Lot Number: 24IBK285; 15) DYNJ06622J, UDI-DI: 10889942725649(each), 40889942725640(case), Lot Number: 24IBQ232; 16) DYNJ83390, UDI-DI: 10195327262914(each), 40195327262915(case), Lot Number: 24IBQ640; 17) DYNJ33236, UDI-DI: 10884389260227(each), 40884389260228(case), Lot Number: 24IBR149; 18) DYNDH1510, UDI-DI: 10193489429749(each), 40193489429740(case), Lot Number: 24IBR168; 19) DYNJ52928D, UDI-DI: 10198459022111(each), 40198459022112(case), Lot Number: 24IBR186; 20) DYNJ35021D, UDI-DI: 10195327242343(each), 40195327242344(case), Lot Number: 24IBR323; 21) SYNJ10253B, UDI-DI: 10193489373592(each), 40193489373593(case), Lot Number: 24IBR379; 22) DYNJ69118B, UDI-DI: 10195327695989(each), 40195327695980(case), Lot Number: 24IBR884; 23) DYNJ48542D, UDI-DI: 10889942579327(each), 40889942579328(case), Lot Number: 24IBS260; 24) DYNJ54596B, UDI-DI: 10889942811786(each), 40889942811787(case), Lot Number: 24IBS271; 25) DYNJ82944, UDI-DI: 10195327218850(each), 40195327218851(case), Lot Number: 24IBS296; 26) DYNJ61549C, UDI-DI: 10193489892383(each), 40193489892384(case), Lot Number: 24JBA841; 27) DYNDH1797A, UDI-DI: 10195327264871(each), 40195327264872(case), Lot Number: 24JBF238; 28) DYNJTS07025, UDI-DI: 10889942602230(each), 40889942602231(case), Lot Number: 24JBL653; 29) DYNJ43539, UDI-DI: 10888277061699(each), 40888277061690(case), Lot Number: 24JBM313; 30) DYNJ30650F, UDI-DI: 10193489854701(each), 40193489854702(case), Lot Number: 24JBM728; 31) DYNJ32844, UDI-DI: 10884389233061(each), 40884389233062(case), Lot Number: 24JBM854; 32) DYNJ38083B, UDI-DI: 10889942670529(each), 40889942670520(case), Lot Number: 24JBM857; 33) DYNJ40036A, UDI-DI: 10889942696840(each), 40889942696841(case), Lot Number: 24JBM867; 34) DYNJ40052B, UDI-DI: 10193489982770(each), 40193489982771(case), Lot Number: 24JBM868; 35) DYNJ41851D, UDI-DI: 10195327429041(each), 40195327429042(case), Lot Number: 24JBM889; 36) DYNJ53406A, UDI-DI: 10889942573844(each), 40889942573845(case), Lot Number: 24JBM917; 37) DYNJ38075B, UDI-DI: 10195327001209(each), 40195327001200(case), Lot Number: 24JBN075; 38) DYNJ49386A, UDI-DI: 10889942292882(each), 40889942292883(case), Lot Number: 24JBN268; 39) DYNJS0815, UDI-DI: 10080196597543(each), 40080196597544(case), Lot Number: 24JBN668; 40) DYNJ63114C, UDI-DI: 10193489870206(each), 40193489870207(case), Lot Number: 24JBN803; 41) DYNJ40456F, UDI-DI: 10195327174798(each), 40195327174799(case), Lot Number: 24JBS603; 42) DYNJ61990A, UDI-DI: 10193489942385(each), 40193489942386(case), Lot Number: 24JBT522; 43) DYNJ52746D, UDI-DI: 10195327469726(each), 40195327469727(case), Lot Number: 24JBT734; 44) DYNJ68243, UDI-DI: 10193489498622(each), 40193489498623(case), Lot Number: 24JBT999; 45) SYNJ10324A, UDI-DI: 10195327017835(each), 40195327017836(case), Lot Number: 24JBU045; 46) DYNJ64867A, UDI-DI: 10195327329204(each), 40195327329205(case), Lot Number: 24JBU398; 47) DYNJ65348, UDI-DI: 10193489268881(each), 40193489268882(case), Lot Number: 24JBU434; 48) DYNJ51781G, UDI-DI: 10198459045974(each), 40198459045975(case), Lot Number: 24JBV555; 49) DYNJ63773A, UDI-DI: 10193489322699(each), 40193489322690(case), Lot Number: 24JBV852; 50) DYNJ69821, UDI-DI: 10193489981452(each), 40193489981453(case), Lot Number: 24JBV870; 51) DYNJ50403C, UDI-DI: 10193489489767(each), 40193489489768(case), Lot Number: 24JBW140; 52) DYNJ81916, UDI-DI: 10195327155339(each), 40195327155330(case), Lot Number: 24JBW146; 53) DYNJHS0614J, UDI-DI: 10193489436211(each), 40193489436212(case), Lot Number: 24JBW161; 54) DYNJ50467C, UDI-DI: 10193489733327(each), 40193489733328(case), Lot Number: 24JBW190; 55) DYNJ47874F, UDI-DI: 10195327579623(each), 40195327579624(case), Lot Number: 24JBW236; 56) DYNDH1905A, UDI-DI: 10198459157615(each), 40198459157616(case), Lot Number: 24JBX271; 57) DYNJ48574, UDI-DI: 10888277913905(each), 40888277913906(case), Lot Number: 24JBX316; 58) DYNJ37641B, UDI-DI: 10889942572977(each), 40889942572978(case), Lot Number: 24JBX693; 59) DYNJCD0138, UDI-DI: 10888277089884(each), 40888277089885(case), Lot Number: 24JBX854; 60) OP8082B, UDI-DI: 10888277589254(each), 40888277589255(case), Lot Number: 24JBX873; 61) DYNJ23138M, UDI-DI: 10193489707007(each), 40193489707008(case), Lot Number: 24JBY245; 62) DYNJS0801, UDI-DI: 10080196799107(each), 40080196799108(case), Lot Number: 24KBA048; 63) DYNJS0803, UDI-DI: 10080196986897(each), 40080196986898(case), Lot Number: 24KBA085; 64) DYNJ35191D, UDI-DI: 10888277786554(each), 40888277786555(case), Lot Number: 24KBA591; 65) DYNDH1836, UDI-DI: 10195327325251(each), 40195327325252(case), Lot Number: 24KBA901; 66) DYNJ48888A, UDI-DI: 10193489772333(each), 40193489772334(case), Lot Number: 24KBB200; 67) DYNJ46724B, UDI-DI: 10889942747412(each), 40889942747413(case), Lot Number: 24KBB420; 68) DYNJ64526B, UDI-DI: 10195327518417(each), 40195327518418(case), Lot Number: 24KBB435; 69) DYNJ67835A, UDI-DI: 10195327486686(each), 40195327486687(case), Lot Number: 24KBB774; 70) DYNJ82944, UDI-DI: 10195327218850(each), 40195327218851(case), Lot Number: 24KBB853; 71) DYNDH1510, UDI-DI: 10193489429749(each), 40193489429740(case), Lot Number: 24KBB886; 72) DYNJ47541F, UDI-DI: 10195327456467(each), 40195327456468(case), Lot Number: 24KBC169; 73) DYNJ40025B, UDI-DI: 10889942896455(each), 40889942896456(case), Lot Number: 24KBC506; 74) DYNJ41797D, UDI-DI: 10195327325817(each), 40195327325818(case), Lot Number: 24KBC508; 75) DYNJ40693F, UDI-DI: 10193489958256(each), 40193489958257(case), Lot Number: 24KBC602; 76) DYNJ57800C, UDI-DI: 10195327493882(each), 40195327493883(case), Lot Number: 24KBC676; 77) DYNJ59158D, UDI-DI: 10195327043872(each), 40195327043873(case), Lot Number: 24KBC686; 78) DYNJ61199A, UDI-DI: 10195327604257(each), 40195327604258(case), Lot Number: 24KBC700; 79) DYNJ61202A, UDI-DI: 10195327604295(each), 40195327604296(case), Lot Number: 24KBC702; 80) DYNJ63838I, UDI-DI: 10195327497606(each), 40195327497607(case), Lot Number: 24KBC726; 81) DYNJ81780D, UDI-DI: 10195327675660(each), 40195327675661(case), Lot Number: 24KBC801; 82) DYNJ83389A, UDI-DI: 10195327366124(each), 40195327366125(case), Lot Number: 24KBD302; 83) DYNJ51930A, UDI-DI: 10889942319350(each), 40889942319351(case), Lot Number: 24KBD436; 84) DYNDH1838, UDI-DI: 10195327323530(each), 40195327323531(case), Lot Number: 24KBD478; 85) CDS983609N, UDI-DI: 10195327209759(each), 40195327209750(case), Lot Number: 24KBD672; 86) DYNJ17529N, UDI-DI: 10195327257743(each), 40195327257744(case), Lot Number: 24KBD810; 87) DYNJ49824I, UDI-DI: 10198459164965(each), 40198459164966(case), Lot Number: 24KBD869; 88) DYNJ39310C, UDI-DI: 10193489982930(each), 40193489982931(case), Lot Number: 24KBE302; 89) DYNJ82946, UDI-DI: 10195327218874(each), 40195327218875(case), Lot Number: 24KBE442; 90) DYNJS0821, UDI-DI: 10080196986651(each), 40080196986652(case), Lot Number: 24KBE489; 91) DYNJS0843, UDI-DI: 10080196597581(each), 40080196597582(case), Lot Number: 24KBE498; 92) DYNJ54596C, UDI-DI: 10198459169519(each), 40198459169510(case), Lot Number: 24KBE672; 93) DYNJ69826, UDI-DI: 10193489982107(each), 40193489982108(case), Lot Number: 24KBE700; 94) DYNJ59157D, UDI-DI: 10198459165580(each), 40198459165581(case), Lot Number: 24KBF080; 95) DYNDH1797A, UDI-DI: 10195327264871(each), 40195327264872(case), Lot Number: 24KBF205; 96) DYNJ40036A, UDI-DI: 10889942696840(each), 40889942696841(case), Lot Number: 24KBF329; 97) DYNJ53406A, UDI-DI: 10889942573844(each), 40889942573845(case), Lot Number: 24KBF357; 98) DYNJ64918A, UDI-DI: 10193489822328(each), 40193489822329(case), Lot Number: 24KBF386; 99) M101413A, UDI-DI: 10193489265019(each), 40193489265010(case), Lot Number: 24KBF904; 100) DYNJ85057A, UDI-DI: 10198459186295(each), 40198459186296(case), Lot Number: 24KBF953; 101) DYNJ40043A, UDI-DI: 10889942739226(each), 40889942739227(case), Lot Number: 24KBG144; 102) DYNJ81328A, UDI-DI: 10195327270506(each), 40195327270507(case), Lot Number: 24KBG157; 103) DYNJ68092, UDI-DI: 10193489484595(each), 40193489484596(case), Lot Number: 24KBG331; 104) DYNDH1209B, UDI-DI: 10889942924080(each), 40889942924081(case), Lot Number: 24KBG698; 105) DYNJ30523B, UDI-DI: 10193489773842(each), 40193489773843(case), Lot Number: 24KBH230; 106) DYNJ69968C, UDI-DI: 10198459113130(each), 40198459113131(case), Lot Number: 24KBH378; 107) DYNJ902287F, UDI-DI: 10195327130367(each), 40195327130368(case), Lot Number: 24LBO456

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

device · product 34 of 34

Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B

Z-1619-2025
Recall number
Z-1619-2025
Initiated
March 03, 2025
Classification
Class II
Status
Ongoing
Quantity
222 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information

1) DYNJ40229A, UDI-DI: 10889942670482(each), 40889942670483(case), Lot Number: 24JBM438; 2) OPK382N, UDI-DI: 10889942686704(each), 40889942686705(case), Lot Number: 24JBN001; 3) DYNJ46723B, UDI-DI: 10889942747405(each), 40889942747406(case), Lot Number: 24JBQ891

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.