Class IIDeviceOngoing

Medline Industries, LP

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.

Reason for recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Details

Recall number: Z-0179-2027
Event ID: 99886
Recall initiated: Sep 2, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 6069 kits
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Northfield, IL, United States
Lot / code info: Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMG028; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMF181; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMD186; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26CMA323; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26BMJ234; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 26ALA854; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADB485; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADA395; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 26ABM111; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25LBH825; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMC475; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMB629; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25KLA526; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25KBP981; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25JDB519; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25JBI857; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25IMC513; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ILA706; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25IDB222; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25IBP736; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25HLA065; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25HBO604; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25GDB198; Medline Product Number/SKU DYNJ905276F, UDI/DI 10198459247965 (each) 40198459247966 (case), Lot Number 25GBS381; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25GBQ923; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25GBJ981; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25FLA160; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25FDA332; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25FBN175; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25EBV301; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25EBH152; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25DLA962; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25DDB837; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25DDA286; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25DBC339; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25CLA883; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25CBS904; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25CBP237; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBG304; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBE419; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA976; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA345; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA067; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25ABU061; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24LBE127; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24KLA163; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24KBR641; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24KBD715; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24JLA181; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24JDA289; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24JBQ903; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBQ698; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBG248; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24IBK612; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24HBT188; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24GDA765; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24GBE280; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24FLA764; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24FDA385; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24FBN519; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24FBM920; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24FBE685; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDB513; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDA174; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24DBH403; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24CBP710; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 24BLA540; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBS351; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBR356; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBI372; Medline Product Number/SKU DYNJ80055, UDI/DI 10195327008741 (each) 40195327008742 (case), Lot Number 24BBD195; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBB443; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24ADC061; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24ADA704; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23LLA416; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23LDA917; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23LBC788; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23KLB157; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23KDA615; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23KBT094; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBP002; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBN905; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23KBC083; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23JDB177; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23IDB906; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23IDB810; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBW076; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23IBI612; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBD027; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23HBP378; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23GDC095; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23FDB307; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23FBI843; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23FBH173; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23EBL944; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23EBJ659; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23DDB819; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23DBN024; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23CDA324; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23CBX130; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23BDB285; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23ADB644; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23ABB068; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBM685; Medline Product Number/SKU CDS940087AK, UDI/DI 10195327257514 (each) 40195327257515 (case), Lot Number 22LBG216; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 22LBF788; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBC322; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22KDB263; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22KDA291; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22JDA178; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22IDA027; Medline Product Number/SKU CDS940087AJ, UDI/DI 10195327210427 (each) 40195327210428 (case), Lot Number 22HBO525; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22HBB637; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22GDA892; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22GBH493; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22GBE442; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22EBN090; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBG548; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBF695; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBA274; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22CBP174; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22BDC466; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22BBY060; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22BBP492; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21LBU758; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21KBH163; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21JBF936; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21IBL720; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21IBJ260; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21HBL624; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 21GDD271; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21GBI183; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 21FBB329; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21EDB082; Medline Product Number/SKU CDS940087AG, UDI/DI 10193489847260 (each) 40193489847261 (case), Lot Number 21EBC900; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21CDA517; Medline Product Number/SKU CDS780025AA, UDI/DI 10193489483932 (each) 40193489483933 (case), Lot Number 21CBD927.