FDAHealthFebruary 2, 2026
B Braun Medical Inc — Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutan
⚠️ 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: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 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
- 0062006430
Additional details
Model/Catalog Number: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 105550 units.
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