Class IIDeviceOngoing

Medline Industries, LP

Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.

Reason for recall

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Details

Recall number: Z-2997-2026
Event ID: 99489
Recall initiated: Jul 8, 2026
Classified: Aug 21, 2026
Reported: Sep 2, 2026
Quantity: 974 kits
Distribution: US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
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 Kit SKU DYNJT6548, UDI/DI 10198459558764 (each) 40198459558765 (case), Lot Number 25JMF561; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDA305; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDB254; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMF418; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMJ129; Medline Kit SKU DYNJ46024F, UDI/DI 10195327237011 (each) 40195327237012 (case), Lot Number 23HBJ773; Medline Kit SKU DYNJ54479C, UDI/DI 10193489460254 (each) 40193489460255 (case), Lot Number 23HBA720; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23BMC930; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23FMD505; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23JMH313; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23LME066; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 22CMG565; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24BME326; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24EMF925; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23AMJ184; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23EMD739; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23IME138; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23KMB648; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMB107; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMH426; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22FMF374; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22KMH219; Medline Kit SKU DYNJ83585, UDI/DI 10195327283179 (each) 40195327283170 (case), Lot Number 23HMC695; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 25CMD816; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IMD021; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IME838; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBJ627; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBL564; Medline Kit SKU PHS396933009C, UDI/DI 10193489753301 (each) 40193489753302 (case), Lot Number 22EDB595