Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 ... recall (B Braun Medical Inc)
Medical deviceClass IIOngoing
Summary: B Braun Medical Inc is recalling 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. C. Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
What is being recalled
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
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. (states named: Texas)
How to tell if yours is affected
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 to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1483-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 2, 2026 |
| Reported | March 11, 2026 |
| Company | B Braun Medical Inc |
| Company location | Bethlehem, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 51300 units |
More recalls from B Braun Medical Inc · all medical device recalls · recalls from February 2026