B Braun Medical Inc 2025-12-03 Health serious FDA
Health · FDA · Recall #FDA-Z-0647-2026
IV Administration Set utilized in gravity IV administration sets and pump administration… Recall
Issued December 3, 2025 · B Braun Medical Inc
In December 2025, B Braun Medical Inc recalled the IV Administration Set utilized in gravity IV administration sets and pump administration…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What you should do
- 1 Stop using IV Administration Set utilized in gravity IV administration sets and pump administration… 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
- December 3, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Recall number
- FDA-Z-0647-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- B Braun Medical Inc has 23 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.