Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY P...
FDA Recall #Z-1388-2026 — Class II — January 7, 2026
Product Description
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G
Reason for Recall
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3561 units
Distribution
Worldwide distribution - US Nationwide.
Code Information
1) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 2) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 3) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21EBQ851; 4) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21DBA951; 5) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21BKA527; 6) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21AKB217; 7) DYNJ0842873J, UDI-DI: 10193489448917(each), 40193489448918(case), Lot Number: 21ADA204; 8) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBI127; 9) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBF322; 10) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22CBF108; 11) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22CLA012; 12) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22BLA508; 13) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21KLA332; 14) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21HLA812; 15) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21CLA325; 16) DYNJ61978A, UDI-DI: 10193489729306(each), 40193489729307(case), Lot Number: 20LDB953; 17) DYNJ63542B, UDI-DI: 10193489398632(each), 40193489398633(case), Lot Number: 23DBP359; 18) DYNJ907452, UDI-DI: 10193489422887(each), 40193489422888(case), Lot Number: 20LBW791; 19) DYNJC2371G, UDI-DI: 10889942494675(each), 40889942494676(case), Lot Number: 23BBT999; 20) PHS853965G, UDI-DI: 10193489249460(each), 40193489249461(case), Lot Number: 21ADA067
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated