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RecallWatchMedical Device Safety
Class IIOngoingZ-1598-2025

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
10195327444068(each), 40195327444069(case)
Lot #
24IBE926; 2) DYNJ45711B
UDI
10193489856149(each), 40193489856140(case)
Lot #
24IBE981; 3) DYNJ45266B
UDI
10193489852417(each), 40193489852418(case)
Lot #
24IBF031; 4) DYNJ80737B
UDI
10198459050855(each), 40198459050856(case)
Lot #
24IBF165; 5) DYNJ67785A
UDI
10193489945638(each), 40193489945639(case)
Lot #
24IBG441; 6) DYNJ49675F
Show 232 more code fields
UDI
10198459113529(each), 40198459113520(case)
Lot #
24IBG617; 7) DYNJ0579176B
UDI
10889942429844(each), 40889942429845(case)
Lot #
24IBG732; 8) DYNJ23615D
UDI
10193489587012(each), 40193489587013(case)
Lot #
24IBG752; 9) DYNJ44752D
UDI
10195327322342(each), 40195327322343(case)
Lot #
24IBG844; 10) DYNJ83155
UDI
10195327236854(each), 40195327236855(case)
Lot #
24IBH261; 11) DYNJ83423
UDI
10195327265410(each), 40195327265411(case)
Lot #
24IBH595; 12) DYNJ64257C
UDI
10195327449445(each), 40195327449446(case)
Lot #
24IBH738; 13) DYNJ30587I
UDI
10198459078866(each), 40198459078867(case)
Lot #
24IBM219; 14) DYNJ58655B
UDI
10198459027475(each), 40198459027476(case)
Lot #
24IBQ285; 15) DYNJ49308F
UDI
10195327631178(each), 40195327631179(case)
Lot #
24IBQ350; 16) DYNJ46736B
UDI
10889942559312(each), 40889942559313(case)
Lot #
24IBQ975; 17) DYNJ27547B
UDI
10198459093616(each), 40198459093617(case)
Lot #
24IBR473; 18) DYNJ14143J
UDI
10195327464806(each), 40195327464807(case)
Lot #
24IBR483; 19) DYNJ80819B
UDI
10195327428983(each), 40195327428984(case)
Lot #
24IBR559; 20) DYNJ47687A
UDI
10888277816879(each), 40888277816870(case)
Lot #
24IBR569; 21) DYNJ86034A
UDI
10198459031649(each), 40198459031640(case)
Lot #
24IBR630; 22) DYNJ909127F
UDI
10198459055423(each), 40198459055424(case)
Lot #
24IBS115; 23) SYNJ10079G
UDI
10195327246822(each), 40195327246823(case)
Lot #
24IBS269; 24) DYNJ58701B
UDI
10198459131592(each), 40198459131593(case)
Lot #
24IBS283; 25) DYNJ83841A
UDI
10195327574314(each), 40195327574315(case)
Lot #
24IBS297; 26) DYNJ40120B
UDI
10193489981353(each), 40193489981354(case)
Lot #
24IBS349; 27) CDS982937O
UDI
10193489965483(each), 40193489965484(case)
Lot #
24IBU511; 28) DYNJ58459A
UDI
10888277739642(each), 40888277739643(case)
Lot #
24IBV583; 29) DYNJ50035F
UDI
10195327436070(each), 40195327436071(case)
Lot #
24IBV702; 30) DYNJ900279F
UDI
10195327577568(each), 40195327577569(case)
Lot #
24JBH126; 31) DYNJ63088B
UDI
10195327358938(each), 40195327358939(case)
Lot #
24JBL176; 32) DYNJ46736B
UDI
10889942559312(each), 40889942559313(case)
Lot #
24JBM344; 33) DYNJ39905A
UDI
10888277801912(each), 40888277801913(case)
Lot #
24JBM389; 34) DYNJ46248F
UDI
10195327293482(each), 40195327293483(case)
Lot #
24JBM542; 35) CDS981214A
UDI
10884389043158(each), 40884389043159(case)
Lot #
24JBM651; 36) DYNJ14102J
UDI
10193489930450(each), 40193489930451(case)
Lot #
24JBM843; 37) DYNJ41815B
UDI
10193489636017(each), 40193489636018(case)
Lot #
24JBM885; 38) DYNJ41952D
UDI
10193489576221(each), 40193489576222(case)
Lot #
24JBM895; 39) DYNJ41961D
UDI
10195327128890(each), 40195327128891(case)
Lot #
24JBM897; 40) DYNJ53404B
UDI
10889942796496(each), 40889942796497(case)
Lot #
24JBM915; 41) DYNJ50018B
UDI
10889942851133(each), 40889942851134(case)
Lot #
24JBN056; 42) DYNJ41939B
UDI
10193489675733(each), 40193489675734(case)
Lot #
24JBN277; 43) DYNJ44555J
UDI
10198459048197(each), 40198459048198(case)
Lot #
24JBN612; 44) DYNJS0302
UDI
10080196798711(each), 40080196798712(case)
Lot #
24JBN666; 45) DYNJ80792
UDI
10195327079505(each), 40195327079506(case)
Lot #
24JBN817; 46) DYNJ67586A
UDI
10198459002199(each), 40198459002190(case)
Lot #
24JBO078; 47) DYNJ57529F
UDI
10195327206390(each), 40195327206391(case)
Lot #
24JBS815; 48) DYNJ44753G
UDI
10195327322359(each), 40195327322350(case)
Lot #
24JBT889; 49) DYNJ80737B
UDI
10198459050855(each), 40198459050856(case)
Lot #
24JBU018; 50) DYNJ80093
UDI
10195327010706(each), 40195327010707(case)
Lot #
24JBU072; 51) DYNJ84446
UDI
10195327365257(each), 40195327365258(case)
Lot #
24JBU122; 52) DYNJ56405C
UDI
10198459004520(each), 40198459004521(case)
Lot #
24JBU143; 53) DYNJS0908
UDI
10080196986972(each), 40080196986973(case)
Lot #
24JBU213; 54) DYNJ36184B
UDI
10884389640401(each), 40884389640402(case)
Lot #
24JBV036; 55) DYNJ84990
UDI
10195327444068(each), 40195327444069(case)
Lot #
24JBV135; 56) DYNJ68529C
UDI
10195327341190(each), 40195327341191(case)
Lot #
24JBV596; 57) DYNJ23615D
UDI
10193489587012(each), 40193489587013(case)
Lot #
24JBV598; 58) DYNJ26597K
UDI
10195327627645(each), 40195327627646(case)
Lot #
24JBV677; 59) DYNJ82943
UDI
10195327218843(each), 40195327218844(case)
Lot #
24JBW194; 60) DYNJ48896
UDI
10888277951167(each), 40888277951168(case)
Lot #
24JBW459; 61) DYNJ83247
UDI
10195327251574(each), 40195327251575(case)
Lot #
24JBW782; 62) DYNJ50465D
UDI
10195327287290(each), 40195327287291(case)
Lot #
24JBX122; 63) DYNJ58655B
UDI
10198459027475(each), 40198459027476(case)
Lot #
24JBX134; 64) DYNJ68411B
UDI
10195327341312(each), 40195327341313(case)
Lot #
24JBX166; 65) CDS982937O
UDI
10193489965483(each), 40193489965484(case)
Lot #
24JBX334; 66) DYNJ50843
UDI
10889942031573(each), 40889942031574(case)
Lot #
24JBY226; 67) DYNJ908898B
UDI
10195327690939(each), 40195327690930(case)
Lot #
24KBA038; 68) DYNJ63692B
UDI
10193489883107(each), 40193489883108(case)
Lot #
24KBA661; 69) DYNJ909127F
UDI
10198459055423(each), 40198459055424(case)
Lot #
24KBA834; 70) DYNJ40136B
UDI
10195327663483(each), 40195327663484(case)
Lot #
24KBB754; 71) DYNJ50035F
UDI
10195327436070(each), 40195327436071(case)
Lot #
24KBB778; 72) DYNJ49308F
UDI
10195327631178(each), 40195327631179(case)
Lot #
24KBB826; 73) DYNJ53510C
UDI
10195327629144(each), 40195327629145(case)
Lot #
24KBB851; 74) DYNJS0310
UDI
10080196942589(each), 40080196942580(case)
Lot #
24KBB859; 75) DYNJ41800G
UDI
10195327468798(each), 40195327468799(case)
Lot #
24KBC609; 76) DYNJ48762A
UDI
10193489488456(each), 40193489488457(case)
Lot #
24KBC636; 77) DYNJ49249
UDI
10888277826120(each), 40888277826121(case)
Lot #
24KBC638; 78) DYNJ69889B
UDI
10195327480479(each), 40195327480470(case)
Lot #
24KBC777; 79) DYNJ84876A
UDI
10198459165917(each), 40198459165918(case)
Lot #
24KBC847; 80) DYNJ64078A
UDI
10198459081248(each), 40198459081249(case)
Lot #
24KBD253; 81) DYNJ80265B
UDI
10195327374938(each), 40195327374939(case)
Lot #
24KBD327; 82) DYNJ36488I
UDI
10193489947946(each), 40193489947947(case)
Lot #
24KBD827; 83) DYNJ41939B
UDI
10193489675733(each), 40193489675734(case)
Lot #
24KBD842; 84) DYNJ85145
UDI
10195327466053(each), 40195327466054(case)
Lot #
24KBE065; 85) DYNJ907536D
UDI
10198459104398(each), 40198459104399(case)
Lot #
24KBE213; 86) DYNJ51836
UDI
10889942216642(each), 40889942216643(case)
Lot #
24KBE294; 87) DYNJ61852B
UDI
10195327211448(each), 40195327211449(case)
Lot #
24KBE319; 88) DYNJ47687A
UDI
10888277816879(each), 40888277816870(case)
Lot #
24KBE434; 89) DYNJ51262C
UDI
10193489958201(each), 40193489958202(case)
Lot #
24KBF353; 90) DYNJ81896B
UDI
10198459155741(each), 40198459155742(case)
Lot #
24KBF571; 91) DYNJ42117A
UDI
10195327285777(each), 40195327285778(case)
Lot #
24KBF961; 92) DYNJ53500D
UDI
10198459086427(each), 40198459086428(case)
Lot #
24KBF969; 93) DYNJ46248F
UDI
10195327293482(each), 40195327293483(case)
Lot #
24KBG033; 94) DYNJ01119D
UDI
10889942663057(each), 40889942663058(case)
Lot #
24KBG043; 95) CDS760086R
UDI
10195327164775(each), 40195327164776(case)
Lot #
24KBG197; 96) DYNJ50018C
UDI
10198459186448(each), 40198459186449(case)
Lot #
24KBG841; 97) DYNJ63246B
UDI
10193489487435(each), 40193489487436(case)
Lot #
24KBG871; 98) DYNJ59096C
UDI
10195327394042(each), 40195327394043(case)
Lot #
24KBG881; 99) DYNJ56405C
UDI
10198459004520(each), 40198459004521(case)
Lot #
24KBG893; 100) DYNJ46742B
UDI
10889942279272(each), 40889942279273(case)
Lot #
24KBG956; 101) DYNJ63588B
UDI
10195327170677(each), 40195327170678(case)
Lot #
24KBH020; 102) CDS982653K
UDI
10198459082030(each), 40198459082031(case)
Lot #
24KBH139; 103) DYNJ61327C
UDI
10195327097103(each), 40195327097104(case)
Lot #
24KBH337; 104) DYNJ81246
UDI
10195327097547(each), 40195327097548(case)
Lot #
24KBH386; 105) DYNJ44990I
UDI
10198459156960(each), 40198459156961(case)
Lot #
24KBH740; 106) DYNJ80274
UDI
10195327018283(each), 40195327018284(case)
Lot #
24KBH796; 107) DYNJ58587B
UDI
10195327637576(each), 40195327637577(case)
Lot #
24KBH881; 108) CDS982395D
UDI
10195327010386(each), 40195327010387(case)
Lot #
24KBK715; 109) DYNJ14143J
UDI
10195327464806(each), 40195327464807(case)
Lot #
24KBK901; 110) CDS985253M
UDI
10198459059889(each), 40198459059880(case)
Lot #
24KBO929; 111) CDS983673J
UDI
10195327382261(each), 40195327382262(case)
Lot #
24KBP694; 112) CDS981214A
UDI
10884389043158(each), 40884389043159(case)
Lot #
24KBQ363; 113) CDS982421M
UDI
10195327210571(each), 40195327210572(case)
Lot #
24KBQ711; 114) DYNJ909127F
UDI
10198459055423(each), 40198459055424(case)
Lot #
24KBR465; 115) DYNJ901498B
UDI
10195327523985(each), 40195327523986(case)
Lot #
24KBR477; 116) DYNJ903503C
UDI
10198459166112(each), 40198459166113(case)
Lot #
24KBS227; 117) DYNJ904834G
UDI
10193489930382(each), 40193489930383(case)
Lot #
24KBS233; 118) CDS982022T
UDI
10195327657581(each), 40195327657582(case)
Lot #
24LBA370; 119) DYNJ908098A
UDI
10195327507251(each), 40195327507252(case)
Lot #
24LBA991; 120) CDS760086R
UDI
10195327164775(each), 40195327164776(case)
Lot #
24LBD961; 121) DYNJ903028M
UDI
10195327665203(each), 40195327665204(case)
Lot #
24LBP333

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

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

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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