FDA Device recall Z-1483-2026
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device des…
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device des… by B Braun Medical, citing the potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1483-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-02 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
Reason
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Identifiers
| code_info | Model/Catalog Number: 7M2802; Primary-DI 4046964787102, Unit of Use- DI 4046964349904; Lot 0062003864, Exp 30APR2032; L…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1483-2026%22
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