Warning
B BRAUN MEDICAL INC Recalls Sterile Water for Injection USP
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0495-2026Drug / Pharmaceutical
B BRAUN MEDICAL INC Recalls Sterile Water for Injection USP
B BRAUN MEDICAL INC · Class II — Moderate Risk
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from B BRAUN MEDICAL INC, initiated on April 2, 2026. Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. This recall covers 24,928 bags, distributed in US Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.