B. Braun Sterile Water for Injection 3000 mL Bags
B. Braun recalls Sterile Water for Injection 3000 mL bags over sterility concerns from potential port leakage.
Immediately stop using the recalled Sterile Water for Injection bags and contact B. Braun Medical Inc. for instructions on return and replacement.
Why it was recalled
B. Braun Medical Inc. is recalling Sterile Water for Injection USP, 3000 mL Pharmacy Bulk Packages due to a lack of assurance of sterility caused by potential leakage from the diaphragm port after foil removal. Use of the affected product may pose a risk of infection.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | 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 18018-3524, 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, USA, NDC: 0264-7388-60. | D-0497-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from B BRAUN MEDICAL INC
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification