{"url_path":"/fda/device/recalls/Z-2009-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:  PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A","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-2009-2026%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":96,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2009-2026\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:  PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A\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 DYNJ86657A:  UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Numbers:  26ABM977, 25KBM387, 25IBG995, 25GBW704.\n\n## Distribution\nWorldwide distribution."}