FDA Drug recall D-0498-2026
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60
- FDA Drug
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60 by B Braun Medical, citing lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0498-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-02 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Identifiers
| ndc | 0264-7389-60 |
|---|---|
| code_info | Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0498-2026%22
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