{"url_path":"/fda/device/recalls/Z-2997-2026","section_key":"summary","section_title":"DEVICE Recall: 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-LAMI…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2997-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":521,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2997-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-08\n**Report date:** 2026-09-02\n\n## Product\nMedline 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.\n\n## Reason\nSpecific 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.\n\n## Affected lots\nMedline 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\n\n## Distribution\nUS Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY."}