FDA Medical devices recall ·
B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model recall
- Recall number
- Z-1481-2026
- Date
- (initiated February 2, 2026)
- Company / brand
- B Braun Medical Inc
824 12th Ave, Bethlehem, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 105550 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1481-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.