B Braun Medical Inc recalls Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version:…

Recall date

February 2, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1481-2026

FDA classification

Class II

Brand / firm

B Braun Medical Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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