{"url_path":"/fda/drug/recalls/D-0497-2026","section_key":"summary","section_title":"DRUG Recall: B BRAUN MEDICAL INC — 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-02","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0497-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"B BRAUN MEDICAL INC"},"word_count":114,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0497-2026\n\n**Recalling firm:** B BRAUN MEDICAL INC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-02\n**Report date:** 2026-04-29\n\n## Product\n0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.\n\n## Reason\nLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.\n\n## Affected lots\nLot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.\n\n## Distribution\nUS Nationwide."}