B. Braun Sterile Water for Injection 3000 mL
B. Braun recalls Sterile Water for Injection 3000 mL bags over sterility and leakage risk.
Stop using the affected product immediately. Contact B. Braun Medical Inc. for instructions on returning the product and obtaining a replacement.
Why it was recalled
B. Braun Medical Inc. is recalling Sterile Water for Injection USP, 3000 mL Pharmacy Bulk Package bags due to a lack of assurance of sterility, with potential for leakage from the diaphragm port once the foil is removed.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | NDC / UPC | Recall # |
|---|---|---|
| DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA | NDC 0264-7387-50 | D-0496-2026 |
| LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA | NDC 0264-7389-60 | D-0498-2026 |
| Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA… | NDC 0264-7385-60 | D-0495-2026 |
| 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524… | NDC 0264-7388-60 | D-0497-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from B Braun Medical Inc
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification