Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

STERILE WATER FOR INJECTION USP Recalled by B BRAUN MEDICAL INC Due to Lack of Assurance of Sterility- Potential for fluid...

Date: August 26, 2025
Company: B BRAUN MEDICAL INC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B BRAUN MEDICAL INC directly.

Affected Products

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

Quantity: 26,316 3000 mL bags

Why Was This Recalled?

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B BRAUN MEDICAL INC

B BRAUN MEDICAL INC has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report