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RecallWatchMedical Device Safety
Class IIOngoingZ-1602-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Refer to RES

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 23, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Refer to RES

Lot / code information

UDI
10193489303360(each), 40193489303361(case)
Lot #
24IBE784; 2) DYNJ50017B
UDI
10889942851126(each), 40889942851127(case)
Lot #
24IBE809; 3) DYNJ68242C
UDI
10198459091568(each), 40198459091569(case)
Lot #
24IBF050; 4) SYNJ10001B
UDI
10195327067977(each), 40195327067978(case)
Lot #
24IBF241; 5) DYNJ42691
UDI
10888277003507(each), 40888277003508(case)
Lot #
24IBF320; 6) DYNJ43775C
Show 330 more code fields
UDI
10889942763191(each), 40889942763192(case)
Lot #
24IBF620; 7) DYNJ54078A
UDI
10193489528633(each), 40193489528634(case)
Lot #
24IBF640; 8) DYNJ39493B
UDI
10889942669998(each), 40889942669999(case)
Lot #
24IBG032; 9) DYNJ0101397O
UDI
10195327661663(each), 40195327661664(case)
Lot #
24IBG201; 10) DYNJ28408J
UDI
10195327279684(each), 40195327279685(case)
Lot #
24IBG536; 11) DYNJ45997C
UDI
10889942684366(each), 40889942684367(case)
Lot #
24IBG574; 12) DYNJ17504G
UDI
10195327224479(each), 40195327224470(case)
Lot #
24IBG595; 13) DYNJ44532D
UDI
10195327463700(each), 40195327463701(case)
Lot #
24IBG706; 14) DYNJ65996C
UDI
10195327621698(each), 40195327621699(case)
Lot #
24IBG871; 15) DYNJ63703B
UDI
10193489883466(each), 40193489883467(case)
Lot #
24IBH017; 16) DYNJ59621A
UDI
10193489685374(each), 40193489685375(case)
Lot #
24IBH300; 17) DYNJ37733B
UDI
10889942775712(each), 40889942775713(case)
Lot #
24IBH634; 18) DYKE1321B
UDI
10193489532890(each), 40193489532891(case)
Lot #
24IBH701; 19) DYNJ24860G
UDI
10889942361618(each), 40889942361619(case)
Lot #
24IBH843; 20) DYNJ81648
UDI
10195327130640(each), 40195327130641(case)
Lot #
24IBH845; 21) DYNJ84619
UDI
10195327386252(each), 40195327386253(case)
Lot #
24IBI031; 22) DYNJHTLD02A
UDI
10193489303360(each), 40193489303361(case)
Lot #
24IBP627; 23) DYNJ69017
UDI
10193489878158(each), 40193489878159(case)
Lot #
24IBP905; 24) DYNJ42913A
UDI
10195327080600(each), 40195327080601(case)
Lot #
24IBQ345; 25) DYNJCHCY01A
UDI
10888277551664(each), 40888277551665(case)
Lot #
24IBQ381; 26) DYNJ62614A
UDI
10193489445466(each), 40193489445467(case)
Lot #
24IBQ618; 27) DYKL1252B
UDI
10889942440016(each), 40889942440017(case)
Lot #
24IBQ716; 28) DYNJ54307A
UDI
10195327327378(each), 40195327327379(case)
Lot #
24IBQ767; 29) DYNJ32910A
UDI
10195327279264(each), 40195327279265(case)
Lot #
24IBR140; 30) DYNJ50747
UDI
10889942020577(each), 40889942020578(case)
Lot #
24IBR572; 31) DYNJ83381A
UDI
10195327366094(each), 40195327366095(case)
Lot #
24IBR622; 32) DYNJHS0525C
UDI
10195327599638(each), 40195327599639(case)
Lot #
24IBR899; 33) DYNJ50581
UDI
10889942008445(each), 40889942008446(case)
Lot #
24IBR902; 34) DYNJ59094
UDI
10889942933501(each), 40889942933502(case)
Lot #
24IBS361; 35) DYNJ84440
UDI
10195327365127(each), 40195327365128(case)
Lot #
24IBS371; 36) DYNJ51611A
UDI
10889942453849(each), 40889942453840(case)
Lot #
24IBS387; 37) DYNJ52804A
UDI
10888277785328(each), 40888277785329(case)
Lot #
24IBS836; 38) DYNJ60191A
UDI
10193489204742(each), 40193489204743(case)
Lot #
24IBU433; 39) DYNJ65996C
UDI
10195327621698(each), 40195327621699(case)
Lot #
24IBV594; 40) DYNJ44962K
UDI
10198459045462(each), 40198459045463(case)
Lot #
24JBA280; 41) DYNJ57753
UDI
10889942774395(each), 40889942774396(case)
Lot #
24JBA828; 42) DYNJ56508G
UDI
10193489734133(each), 40193489734134(case)
Lot #
24JBA985; 43) DYNJ60802C
UDI
10195327404666(each), 40195327404667(case)
Lot #
24JBF137; 44) DYNJ903254A
UDI
10889942632428(each), 40889942632429(case)
Lot #
24JBK752; 45) DYNJ66251
UDI
10193489324778(each), 40193489324779(case)
Lot #
24JBL345; 46) DYNJ52109
UDI
10889942239825(each), 40889942239826(case)
Lot #
24JBL351; 47) DYNJ83154
UDI
10195327236847(each), 40195327236848(case)
Lot #
24JBL827; 48) DYNJ40595A
UDI
10889942818648(each), 40889942818649(case)
Lot #
24JBM390; 49) DYNJ48101C
UDI
10193489712520(each), 40193489712521(case)
Lot #
24JBM496; 50) DYNJ62295B
UDI
10195327209933(each), 40195327209934(case)
Lot #
24JBM500; 51) DYNJ33949G
UDI
10889942682515(each), 40889942682516(case)
Lot #
24JBM602; 52) DYNJ34948C
UDI
10198459130076(each), 40198459130077(case)
Lot #
24JBM855; 53) DYNJ39374B
UDI
10889942670871(each), 40889942670872(case)
Lot #
24JBM858; 54) DYNJ41860B
UDI
10193489662634(each), 40193489662635(case)
Lot #
24JBM890; 55) DYNJ66255
UDI
10193489324983(each), 40193489324984(case)
Lot #
24JBM944; 56) DYNJ62348C
UDI
10195327538569(each), 40195327538560(case)
Lot #
24JBN288; 57) DYNJ52891A
UDI
10889942819805(each), 40889942819806(case)
Lot #
24JBN389; 58) DYNJ84784A
UDI
10195327447922(each), 40195327447923(case)
Lot #
24JBN412; 59) SYNJ10001B
UDI
10195327067977(each), 40195327067978(case)
Lot #
24JBN423; 60) DYNJ37145F
UDI
10195327467692(each), 40195327467693(case)
Lot #
24JBN425; 61) DYNJ85241
UDI
10195327482657(each), 40195327482658(case)
Lot #
24JBO099; 62) DYNJ52921B
UDI
10889942739240(each), 40889942739241(case)
Lot #
24JBO261; 63) DYNJ82242
UDI
10195327181420(each), 40195327181421(case)
Lot #
24JBO566; 64) CDS984266J
UDI
10193489862386(each), 40193489862387(case)
Lot #
24JBO721; 65) DYNJ24478G
UDI
10193489866599(each), 40193489866590(case)
Lot #
24JBR846; 66) DYNJ54741A
UDI
10889942921164(each), 40889942921165(case)
Lot #
24JBT042; 67) DYNJ83931
UDI
10195327315351(each), 40195327315352(case)
Lot #
24JBT083; 68) DYNJ57965B
UDI
10195327390037(each), 40195327390038(case)
Lot #
24JBT485; 69) DYNJ67974
UDI
10193489462319(each), 40193489462310(case)
Lot #
24JBT495; 70) DYNJ62128A
UDI
10193489449877(each), 40193489449878(case)
Lot #
24JBT723; 71) DYNJ81969C
UDI
10198459003592(each), 40198459003593(case)
Lot #
24JBT793; 72) DYNJ69017
UDI
10193489878158(each), 40193489878159(case)
Lot #
24JBT855; 73) DYNJ48102C
UDI
10193489712537(each), 40193489712538(case)
Lot #
24JBT937; 74) DYNJ43790
UDI
10888277068711(each), 40888277068712(case)
Lot #
24JBT972; 75) SYNJ10266A
UDI
10193489785111(each), 40193489785112(case)
Lot #
24JBU049; 76) DYNJ50747
UDI
10889942020577(each), 40889942020578(case)
Lot #
24JBU066; 77) DYNJ44745B
UDI
10193489225693(each), 40193489225694(case)
Lot #
24JBU107; 78) DYNJ49508A
UDI
10193489704013(each), 40193489704014(case)
Lot #
24JBU167; 79) DYNJ49255B
UDI
10198459165023(each), 40198459165024(case)
Lot #
24JBU462; 80) DYNJ39064
UDI
10884389736838(each), 40884389736839(case)
Lot #
24JBU474; 81) DYNJ65869
UDI
10193489304039(each), 40193489304030(case)
Lot #
24JBV140; 82) DYNJ46786G
UDI
10193489204353(each), 40193489204354(case)
Lot #
24JBV421; 83) DYNJ35732D
UDI
10889942140701(each), 40889942140702(case)
Lot #
24JBV518; 84) DYNJ68390C
UDI
10195327341671(each), 40195327341672(case)
Lot #
24JBV597; 85) DYNJ48474G
UDI
10888277767867(each), 40888277767868(case)
Lot #
24JBV613; 86) DYNJ54609C
UDI
10198459046452(each), 40198459046453(case)
Lot #
24JBV668; 87) DYNJ63703B
UDI
10193489883466(each), 40193489883467(case)
Lot #
24JBV847; 88) DYNJ84831A
UDI
10198459136962(each), 40198459136963(case)
Lot #
24JBV896; 89) DYNJ61473
UDI
10193489572315(each), 40193489572316(case)
Lot #
24JBW127; 90) DYNJ61467
UDI
10193489572261(each), 40193489572262(case)
Lot #
24JBW164; 91) DYNJ59370B
UDI
10198459165801(each), 40198459165802(case)
Lot #
24JBW172; 92) DYNJ36096F
UDI
10195327654085(each), 40195327654086(case)
Lot #
24JBW181; 93) DYNJ37318F
UDI
10193489672756(each), 40193489672757(case)
Lot #
24JBW188; 94) DYNJ55425B
UDI
10193489297416(each), 40193489297417(case)
Lot #
24JBW462; 95) DYNJ51016
UDI
10889942111213(each), 40889942111214(case)
Lot #
24JBW498; 96) DYNJ19845K
UDI
10888277851030(each), 40888277851031(case)
Lot #
24JBX126; 97) PHS419284011D
UDI
10198459132124(each), 40198459132125(case)
Lot #
24JBX226; 98) DYKL1252B
UDI
10889942440016(each), 40889942440017(case)
Lot #
24JBX632; 99) DYNJ45044D
UDI
10193489235500(each), 40193489235501(case)
Lot #
24JBX706; 100) DYNJ45997C
UDI
10889942684366(each), 40889942684367(case)
Lot #
24JBX711; 101) DYNJ57753
UDI
10889942774395(each), 40889942774396(case)
Lot #
24JBX748; 102) DYNJ58401A
UDI
10889942969586(each), 40889942969587(case)
Lot #
24JBX751; 103) DYNJ55206A
UDI
10193489727067(each), 40193489727068(case)
Lot #
24JBX991; 104) DYNJ68761A
UDI
10198459031847(each), 40198459031848(case)
Lot #
24JBY188; 105) DYNJ44858J
UDI
10195327127336(each), 40195327127337(case)
Lot #
24JBY279; 106) DYNJ64353A
UDI
10193489285871(each), 40193489285872(case)
Lot #
24KBA223; 107) DYNJ44037D
UDI
10195327038748(each), 40195327038749(case)
Lot #
24KBA571; 108) DYNJ61350
UDI
10193489560992(each), 40193489560993(case)
Lot #
24KBA573; 109) DYNJ0373855R
UDI
10198459062193(each), 40198459062194(case)
Lot #
24KBA650; 110) DYNJ57039B
UDI
10193489353433(each), 40193489353434(case)
Lot #
24KBA692; 111) DYNJ30550F
UDI
10198459130946(each), 40198459130947(case)
Lot #
24KBB141; 112) DYNJ36951A
UDI
10884389666630(each), 40884389666631(case)
Lot #
24KBB214; 113) DYNJ56508G
UDI
10193489734133(each), 40193489734134(case)
Lot #
24KBB217; 114) DYNJ30550F
UDI
10198459130946(each), 40198459130947(case)
Lot #
24KBB400; 115) DYNJ41724
UDI
10888277021488(each), 40888277021489(case)
Lot #
24KBB417; 116) DYNJ60250A
UDI
10198459015274(each), 40198459015275(case)
Lot #
24KBB762; 117) DYNJ56862D
UDI
10195327642969(each), 40195327642960(case)
Lot #
24KBB799; 118) DYNJ65800
UDI
10193489291278(each), 40193489291279(case)
Lot #
24KBB811; 119) DYNJ61287
UDI
10193489554854(each), 40193489554855(case)
Lot #
24KBC474; 120) DYNJ69943C
UDI
10198459057359(each), 40198459057350(case)
Lot #
24KBC517; 121) DYNJ16105F
UDI
10889942364169(each), 40889942364160(case)
Lot #
24KBC556; 122) DYNJ17504G
UDI
10195327224479(each), 40195327224470(case)
Lot #
24KBC559; 123) DYNJ37032F
UDI
10193489637175(each), 40193489637176(case)
Lot #
24KBC579; 124) DYNJ39496A
UDI
10889942670345(each), 40889942670346(case)
Lot #
24KBC591; 125) DYNJ60396
UDI
10193489500301(each), 40193489500302(case)
Lot #
24KBC689; 126) DYNJ61364A
UDI
10193489722116(each), 40193489722117(case)
Lot #
24KBC706; 127) DYNJ64353A
UDI
10193489285871(each), 40193489285872(case)
Lot #
24KBC729; 128) DYNJ67867C
UDI
10198459158490(each), 40198459158491(case)
Lot #
24KBC757; 129) DYNJ81788
UDI
10195327143114(each), 40195327143115(case)
Lot #
24KBC802; 130) DYNJ86504
UDI
10195327643690(each), 40195327643691(case)
Lot #
24KBC868; 131) SYNJ10001B
UDI
10195327067977(each), 40195327067978(case)
Lot #
24KBC906; 132) DYNJ43428
UDI
10888277051263(each), 40888277051264(case)
Lot #
24KBD224; 133) DYNJ41941D
UDI
10193489753707(each), 40193489753708(case)
Lot #
24KBD843; 134) DYNJ44028A
UDI
10889942135691(each), 40889942135692(case)
Lot #
24KBD852; 135) DYNJ51865A
UDI
10889942322633(each), 40889942322634(case)
Lot #
24KBD881; 136) DYNJ53122B
UDI
10193489321227(each), 40193489321228(case)
Lot #
24KBD891; 137) DYNJ54064B
UDI
10198459155413(each), 40198459155414(case)
Lot #
24KBD896; 138) DYNJ58341
UDI
10889942842438(each), 40889942842439(case)
Lot #
24KBE274; 139) DYNJ48017F
UDI
10198459129049(each), 40198459129040(case)
Lot #
24KBE389; 140) DYNJ56857G
UDI
10195327614669(each), 40195327614660(case)
Lot #
24KBE656; 141) DYNJ60279C
UDI
10195327441760(each), 40195327441761(case)
Lot #
24KBF085; 142) DYNJ33451L
UDI
10198459169687(each), 40198459169688(case)
Lot #
24KBF135; 143) DYNJ32910A
UDI
10195327279264(each), 40195327279265(case)
Lot #
24KBF321; 144) DYNJ40110
UDI
10884389837849(each), 40884389837840(case)
Lot #
24KBF330; 145) DYNJ54033
UDI
10889942457588(each), 40889942457589(case)
Lot #
24KBF361; 146) DYNJ62502
UDI
10193489664874(each), 40193489664875(case)
Lot #
24KBG152; 147) DYNJ15962I
UDI
10889942364138(each), 40889942364139(case)
Lot #
24KBG286; 148) DYNJ51162
UDI
10889942141821(each), 40889942141822(case)
Lot #
24KBG849; 149) DYNJ23098K
UDI
10193489213331(each), 40193489213332(case)
Lot #
24KBG919; 150) DYNJ54307A
UDI
10195327327378(each), 40195327327379(case)
Lot #
24KBG970; 151) DYNDH1606
UDI
10193489844771(each), 40193489844772(case)
Lot #
24KBH207; 152) DYNJ40391
UDI
10884389864531(each), 40884389864532(case)
Lot #
24KBH247; 153) DYNJ54033
UDI
10889942457588(each), 40889942457589(case)
Lot #
24KBH291; 154) DYNJ58419B
UDI
10193489915938(each), 40193489915939(case)
Lot #
24KBH312; 155) DYNJ69967B
UDI
10198459070532(each), 40198459070533(case)
Lot #
24KBH377; 156) DYNJ68519A
UDI
10193489916041(each), 40193489916042(case)
Lot #
24KBH523; 157) DYNJ0858275B
UDI
10889942137251(each), 40889942137252(case)
Lot #
24KBH791; 158) DYNJ52804A
UDI
10888277785328(each), 40888277785329(case)
Lot #
24KBH845; 159) DYNJ85345A
UDI
10198459111549(each), 40198459111540(case)
Lot #
24KBI150; 160) DYNJ55866C
UDI
10198459126093(each), 40198459126094(case)
Lot #
24KBK546; 161) DYNJ81892D
UDI
10198459048104(each), 40198459048105(case)
Lot #
24KBM589; 162) DYNJ909278A
UDI
10195327605247(each), 40195327605248(case)
Lot #
24KBP718; 163) DYNJ903255A
UDI
10889942632435(each), 40889942632436(case)
Lot #
24KBQ385; 164) CDS980470D
UDI
10889942965045(each), 40889942965046(case)
Lot #
24KBQ708; 165) CDS982696K
UDI
10193489441406(each), 40193489441407(case)
Lot #
24KBR961; 166) DYNJ907550B
UDI
10195327076320(each), 40195327076321(case)
Lot #
24LBD358; 167) CDS840343K
UDI
10888277865693(each), 40888277865694(case)
Lot #
24LBD743; 168) CDS983099K
UDI
10198459020377(each), 40198459020378(case)
Lot #
24LBE132; 169) DYNJ904853A
UDI
10193489630978(each), 40193489630979(case)
Lot #
24LBJ828; 170) DYNJ901896C
UDI
10193489553789(each), 40193489553780(case)
Lot #
24LBL495

What the firm is doing

An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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