B BRAUN MEDICAL INC 2025-09-24 Health serious FDA
Health · FDA · Recall #FDA-D-0652-2025
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA… Recall
Issued September 24, 2025 · B BRAUN MEDICAL INC
In September 2025, B BRAUN MEDICAL INC recalled the STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
What you should do
- 1 Stop using STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact B BRAUN MEDICAL INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- B BRAUN MEDICAL INC
- Category
- Health
- Recall date
- September 24, 2025
- Units affected
- Not reported
- Sold at
- U.S. Nationwide
- Recall number
- FDA-D-0652-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- B BRAUN MEDICAL INC has 7 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.