Multi-event August 2025 FDA Recall Sterile Water by B Braun Medical Inc
This Multi-event Class II drug recall was voluntarily initiated by B Braun Medical Inc on August 26, 2025 for the product Sterile Water. The FDA reported the reason for recall as lack of assurance of sterility- potential for fluid leakage from the port due to port misalignment.. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0653-2025
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
08-26-2025
09-24-2025
16,228 3000 mL bags
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B BRAUN MEDICAL INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Batch or Lot Expiration Information
Lot# : : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Affected Packages Involved in this Recall
Recall Number: D-0652-2025
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
08-26-2025
09-24-2025
26,316 3000 mL bags
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B BRAUN MEDICAL INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Batch or Lot Expiration Information
Lot# : J3L519, J3L528, Exp.: 31AUG2026
Lot# : J4C522, J4C523, Exp.:28FEB2027
