LACTATED RINGER'S IRRIGATION — Class II drug recall D-0498-2026
Ongoing recall by B BRAUN MEDICAL INC, reported 2026-04-29, distributed nationwide. Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
| Recall number | D-0498-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B BRAUN MEDICAL INC, Allentown, PA, United States |
| Recall initiated | 2026-04-02 |
| Classified | 2026-04-28 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 54,540 bags |
| Reason classes | sterility, packaging |
| NDC | 00264-7389, 00264-7389-60 |
| Lot numbers | J5E234, J5E236, J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175 |
| Expiration dates | 2028-04-30, 2028-05-31 |
Product
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Reason for recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0498-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.