B. Braun Medical Inc. recalled 26,316 bags of Sterile Water for Injection on August 26, 2025. The recall affects the 3000 mL product due to potential fluid leakage from a misaligned port. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
The recalled product is Sterile Water for Injection, 3000 mL, with NDC 0264-7385-60. The affected lot numbers include J3L519, J3L528, J4C522, and J4C523. The product was distributed nationwide in the U.S.
The recall stems from a lack of assurance of sterility, posing a high risk of contamination. Misalignment of the port can lead to fluid leakage, which may compromise patient safety.
As of now, there are no reported injuries or incidents associated with the recalled product. The FDA classified this recall as Class II.
Stop using the recalled Sterile Water for Injection immediately. Contact B. Braun Medical Inc. or your healthcare provider for further guidance.
For more information, visit the FDA website or contact B. Braun Medical Inc. at their customer service number.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.