FDAHealthFebruary 2, 2026
B Braun Medical Inc — 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
⚠️ The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 2, 2026
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
What's affected?
- 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
- Brand
- B Braun Medical Inc
- Lot code
- 0062003864
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 51300 units.
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