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.
Issued by
FDA
Distribution: Nationwide (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
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.