Class IIReported 2026-03-11

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

Recalled by B Braun Medical Inc

Reason for Recall

The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

Recall Number

Z-1481-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-02-02

Reported

2026-03-11

Distribution

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

Code Info

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.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.