FDA Medical devices recall ·
B. Braun Product Name: 21GA WINGED INF SET Model recall
- Recall number
- Z-1483-2026
- 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
- 51300 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
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: 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.
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-1483-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.