{"url_path":"/fda/drug/recalls/D-0498-2026","section_key":"summary","section_title":"DRUG Recall: B BRAUN MEDICAL INC — LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.","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-0498-2026%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":92,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0498-2026\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\nLACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.\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 # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161,  J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.\n\n## Distribution\nUS Nationwide."}