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.

Class II

Recalling firm: Medline Industries, LP
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.
Affected products (lot / model / serial): 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 produ
Units affected: 8374 kits
Distribution pattern: US Nationwide distribution.
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-0171-2027
Recall initiated: September 2, 2026
FDA classification date: October 15, 2026
FDA report date: October 21, 2026
FDA event ID: 99886
Last updated on HTM Vibe: October 27, 2026

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