Class IIDeviceOngoing

Medline Industries, LP

Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product number/SKU DYNJ68420D; 5) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692J; 6) PRODUCT VASCULAR LAFAYETTE, Medline product number/SKU DYNJ908620D; 7) CHRISTUS SPOHN AV ACCESS PACK, Medline product number/SKU DYNJ60973A; 8) TOL VEIN PACK, Medline product number/SKU DYNJ80861F; 9) THROMBECTOMY PACK-LF, Medline product number/SKU DYNJ0160348B; 10) VEIN PACK, Medline product number/SKU DYNJ67308A; 11) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692I; 12) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692G; 13) BYPASS ACCESSORY, Medline product number/SKU DYNJ52036F; 14) TOL VEIN PACK, Medline product number/SKU DYNJ80861C; 15) MANSFIELD ACCESS GRAFT, Medline product number/SKU DYNJ909985; 16) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732I; 17) CAROTID ENDARTERECTOMY PK, Medline product number/SKU DYNJ85516; 18) RADIAL ARTERY PACK, Medline product number/SKU DYNJ83938; 19) AV FISTULA PACK, Medline product number/SKU DYNJ01966N; 20) FH A V FISTULA PACK-LF, Medline product number/SKU DYNJ51804G; 21) VEIN PACK SHD, Medline product number/SKU DYNJ68420C; 22) VEIN PACK SHD, Medline product number/SKU DYNJ68420B; 23) AV FISTULA, Medline product number/SKU DYNJ906945; 24) VEIN PACK SHD, Medline product number/SKU DYNJ68420A; 25) MHC AV FISTULA, Medline product number/SKU DYNJ903705G.

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-0171-2027
Event ID: 99886
Recall initiated: Sep 2, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 8374 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 DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 26BMB707; Medline product number/SKU DYNJ0665837G, UDI/DI 10198459543685 (each) 40198459543686 (case), Lot Number 26BBG404; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 26AMI490; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 26ABM059; Medline product number/SKU DYNJ0665837G, UDI/DI 10198459543685 (each) 40198459543686 (case), Lot Number 26ABC613; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25LDB280; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25LBA755; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25KMJ136; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25KBH758; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25JMK339; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25JDB137; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25JBW131; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25IMF439; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25IBO322; Medline product number/SKU DYNJ60973A, UDI/DI 10198459037948 (each) 40198459037949 (case), Lot Number 25IBE177; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25HME176; Medline product number/SKU DYNJ80861F, UDI/DI 10198459398384 (each) 40198459398385 (case), Lot Number 25HBP381; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25HBL650; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 25GDB473; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25GDA168; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25GBW279; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25GBE133; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25FMB034; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25FDA914; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25FDA450; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25FBF590; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25EMF399; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25EBG978; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25CMG772; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 25CBR821; Medline product number/SKU DYNJ905692I, UDI/DI 10198459195167 (each) 40198459195168 (case), Lot Number 25BDB456; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 25BDA784; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 25BBN759; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25BBB945; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25AMI745; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25AMH019; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25AMG519; Medline product number/SKU DYNJ905692I, UDI/DI 10198459195167 (each) 40198459195168 (case), Lot Number 25ADA749; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 25ADA594; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25ABQ722; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 25ABQ316; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25ABB193; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 24LMD985; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24LDA353; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24KDA598; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24KBT683; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24KBN817; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24IBB060; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 24HMK312; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 24HMJ371; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24HDA022; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24HBS349; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 24GME662; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24GBB730; Medline product number/SKU DYNJ905692G, UDI/DI 10198459024146 (each) 40198459024147 (case), Lot Number 24FDB212; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24FBM287; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24EBR396; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24DDB695; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24DBP489; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24DBC279; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 24CBD982; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24BBM799; Medline product number/SKU DYNJ80861C, UDI/DI 10195327506117 (each) 40195327506118 (case), Lot Number 24ABS359; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24ABE288; Medline product number/SKU DYNJ909985, UDI/DI 10195327531911 (each) 40195327531912 (case), Lot Number 24ABB464; Medline product number/SKU DYNJ0826732I, UDI/DI 10193489377972 (each) 40193489377973 (case), Lot Number 23LME164; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23LMA870; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23LBS811; Medline product number/SKU DYNJ85516, UDI/DI 10195327511593 (each) 40195327511594 (case), Lot Number 23LBR472; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23LBL475; Medline product number/SKU DYNJ85516, UDI/DI 10195327511593 (each) 40195327511594 (case), Lot Number 23LBE170; Medline product number/SKU DYNJ0826732I, UDI/DI 10193489377972 (each) 40193489377973 (case), Lot Number 23KMF466; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 23KDC246; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23KBJ444; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23KBH513; Medline product number/SKU DYNJ85516, UDI/DI 10195327511593 (each) 40195327511594 (case), Lot Number 23JBI659; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23JBG813; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 23JBF754; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23JBC969; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23IBT687; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23IBL104; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23IBJ790; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23HMH042; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 23HDA183; Medline product number/SKU DYNJ83938, UDI/DI 10195327317232 (each) 40195327317233 (case), Lot Number 23HBO900; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23GME764; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23GBR115; Medline product number/SKU DYNJ01966N, UDI/DI 10193489383768 (each) 40193489383769 (case), Lot Number 23FMG009; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23FBT240; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23FBS476; Medline product number/SKU DYNJ01966N, UDI/DI 10193489383768 (each) 40193489383769 (case), Lot Number 23EMF846; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23EBJ222; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23DDB964; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23DDB513; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23CDC117; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23CBT125; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23BDB219; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23AME485; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22OBM668; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22LBB746; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBW158; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBQ170; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBE339; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBA312; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22JME166; Medline product number/SKU DYNJ01966N, UDI/DI 10193489383768 (each) 40193489383769 (case), Lot Number 22IMA429; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22IDB621; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22IBR892; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22HDB275; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22HBG228; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22GDB613; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22GDA289; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22GBA328; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22FMG964; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22FBE109; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22FBE104; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22FBA284; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22EDB536; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22EDB062; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22EBN485; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22DBO990; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22CBS193; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 22CBP282; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22CBJ075; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22BDA696; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22ADB771; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22ADB470; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22ABJ294; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 22ABF980; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 21LBA620; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 21KDA674; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 21KBV460; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 21KBS378; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 21KBI602; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 21KBF475; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21JDB751; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21JBB317; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21IDA765; Medline product number/SKU DYNJ903705G, UDI/DI 10193489345506 (each) 40193489345507 (case), Lot Number 21IBX705; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21HDC282; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21HDA988; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 21HDA843; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 21HBP947; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21HBE372; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21GBL267; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21FDB477; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21FBP175; Medline product number/SKU DYNJ903705G, UDI/DI 10193489345506 (each) 40193489345507 (case), Lot Number 21FBI212; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21FBE487; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21FBC661; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21DDB231; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21DBK091; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21DBD028; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 21BDB946; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21ADB109.