FDAClass II · Medical device · Recalled May 13, 2026

Medline Convenience Kits recall — Medline Industries, LP

Hazard: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2091-2026
Brand: Medline Industries
Classification: Class II
Units affected: 6961 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DYNJ32328; 6) OR ANGIO PACK-LF, Model Number:DYNJ43415C; 7) ANGIO PACK II, Model Number:DYNJ44066A; 8) SOUTH CATH LAB PACK, Model Number:DYNJ61978A; 9) BIOPSY ANGIO TRAY ALEX, Model Number:DYNJ63542B; 10) SURGICAL TECH KIT, Model Number:DYNJ907452; 11) ANGIOGRAPHY PACK, Model Number:DYNJC2371G; 12) SPECTRUM HEALTH CATH PACK-LF, Model Number:PHS853965G

Affected products

Medline Convenience Kits

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: 1) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23ABN008; 2) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23CBM469; 3) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23EBH500; 4) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23GBE369; 5) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23IBE051; 6) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23IBU695; 7) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23KBD600; 8) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23LBC152; 9) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24ABR800; 10) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24CBC183; 11) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24DBS738; 12) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24FBN230; 13) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24HBB532; 14) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 15) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 16) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23LBJ521; 17) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21AKB217; 18) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21BKA527; 19) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21DBA951; 20) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21EBQ851; 21) DYNJ0842873J, UDI-DI: 10193489448917(each), 40193489448918(case), Lot Number: 21ADA204; 22) DYNJ32328, UDI-DI: 10884389206669(each), 40884389206660(case), Lot Number: 24DBM071; 23) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 23HBT948; 24) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22CBF108; 25) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBF322; 26) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBI127; 27) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21CLA325; 28) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21HLA812; 29) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21KLA332; 30) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22BLA508; 31) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22CLA012; 32) DYNJ61978A, UDI-DI: 10193489729306(each), 40193489729307(case), Lot Number: 20LDB953; 33) DYNJ63542B, UDI-DI: 10193489398632(each), 40193489398633(case), Lot Number: 23DBP359; 34) DYNJ907452, UDI-DI: 10193489422887(each), 40193489422888(case), Lot Number: 20LBW791; 35) DYNJC2371G, UDI-DI: 10889942494675(each), 40889942494676(case), Lot Number: 23BBT999; 36) PHS853965G, UDI-DI: 10193489249460(each), 40193489249461(case), Lot Number: 21ADA067
Distribution: Worldwide - US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 98642
Recall initiated: January 7, 2026
FDA classified: May 7, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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