0 — Class II drug recall D-0353-2025
Ongoing recall by B. Braun Medical Inc, reported 2025-04-16, distributed nationwide. Presence of Particulate Matter
| Recall number | D-0353-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc, Irvine, CA, United States |
| Recall initiated | 2025-03-31 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 32,256 bottles |
| Reason classes | specification failure |
| NDC | 00264-2201, 00264-2201-00, 00264-2201-10, 00264-2201-50, 00264-2201-70 |
| Lot numbers | J4K936 |
| Expiration dates | 2027-07-31 |
Product
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
Reason for recall
Presence of Particulate Matter
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-0353-2025. 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.