Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software V...
FDA Recall #Z-1483-2026 — Class II — February 2, 2026
Product Description
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 for Recall
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Recalling Firm
B Braun Medical Inc — Bethlehem, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
51300 units
Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Code Information
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
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated