{"url_path":"/fda/device/recalls/Z-2995-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical convenience kits, labeled as:    1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545;   2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A;   3) ENT SINUS PACK, Medline Kit SKU DYNJ89001;   4) THYROID ENT, Medline Kit SKU DYNJ908641.","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-2995-2026%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":265,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2995-2026\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) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545;   2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A;   3) ENT SINUS PACK, Medline Kit SKU DYNJ89001;   4) THYROID ENT, Medline Kit SKU DYNJ908641.\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 SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 25JMG396;  Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 26AMH848;  Medline SKU Number DYNJ88056A, UDI 10198459372667 (each) 40198459372668 (case), Lot Number 25FMD894;  Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25JMH786;  Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF523;  Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF530;  Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 26CMD479;  Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABD437;  Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABO388;  Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23EBA762;  Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23HBG168;  Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23KBW672.\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."}