B Braun Medical Inc recalls Brand Name: B. Braun Product Name: 21GA WINGED INF SET
- Recalling company
- B Braun Medical Inc
- Product
- Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
- Reason
- The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 2, 2026
- Reported
- Mar 11, 2026
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
- Status
- Ongoing
- Quantity
- 51300 units
- Lot / codes
- Model/Catalog Number: 7M2802; Primary-DI 4046964787102, Unit of Use- DI 4046964349904; Lot 0062003864, Exp 30APR2032; Lot 0062004133, Exp 30JUN2032; Lot 0062006454, Exp 31JUL2032; Lot 0062028929, Exp 31AUG2032; Lot 0062037141, Exp 30SEP2032, Lot 0062037691, Exp 30SEP2032.
- Company location
- Bethlehem, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1483-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1483-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.