{"url_path":"/fda/device/recalls/Z-2023-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J;   2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447;   3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2023-2026%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":370,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2023-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-19\n**Report date:** 2026-05-06\n\n## Product\nMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J;   2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447;   3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.\n\n## Reason\nDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.\n\n## Affected lots\nMedline Kit Number/SKU DYNJ58648J:  UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23JMD938;  Medline Kit Number/SKU DYNJ58648J:  UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23HMG766;  Medline Kit Number/SKU DYNJ58648J:  UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23DMD129;  Medline Kit Number/SKU DYNJ58648J:  UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 22KMD675;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23JBM687;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23EBD581;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23DBH247;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23CBS705;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23BBF189;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22JBF016;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22HBR972;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO928;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO407;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 24ABP390;  Medline Kit Number/SKU DYNJ66447:  UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23LBN206;  Medline Kit Number/SKU DYNJ908362B:  UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23KLA222;  Medline Kit Number/SKU DYNJ908362B:  UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23JLA551;  Medline Kit Number/SKU DYNJ908362B:  UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23ILA611;  Medline Kit Number/SKU DYNJ908362B:  UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23HLA926;  Medline Kit Number/SKU DYNJ908362B:  UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23FLA515;  Medline Kit Number/SKU DYNJ908362B:  UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23LLA801.\n\n## Distribution\nWorldwide distribution."}