{"url_path":"/fda/device/recalls/Z-2035-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B;   2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C;   3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.","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-2035-2026%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":326,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2035-2026\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. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B;   2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C;   3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.\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 DYNJ904269B:  UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21KBM212;  Medline Kit Number/SKU DYNJ904269B:  UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21IBT678;  Medline Kit Number/SKU DYNJ904269B:  UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21GBF973;  Medline Kit Number/SKU DYNJ904269B:  UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21EBR775;  Medline Kit Number/SKU DYNJ904269B:  UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21DBH715;  Medline Kit Number/SKU DYNJ904269B:  UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21BBI962;  Medline Kit Number/SKU DYNJ904269C:  UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22HBO534;  Medline Kit Number/SKU DYNJ904269C:  UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBY086;  Medline Kit Number/SKU DYNJ904269C:  UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBG752;  Medline Kit Number/SKU DYNJ904269C:  UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22CBY116;  Medline Kit Number/SKU DYNJ904269C:  UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22ABS155;  Medline Kit Number/SKU DYNJ904269C:  UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 21LBF114;  Medline Kit Number/SKU DYNJ904269D:  UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23JBN926;  Medline Kit Number/SKU DYNJ904269D:  UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23FBE547;  Medline Kit Number/SKU DYNJ904269D:  UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23EBI633;  Medline Kit Number/SKU DYNJ904269D:  UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23DBA946;  Medline Kit Number/SKU DYNJ904269D:  UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23CBD209;  Medline Kit Number/SKU DYNJ904269D:  UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23ABH377.\n\n## Distribution\nWorldwide distribution."}