Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Recalled by B Braun Medical Inc Due to The potential for the needle tip to be...

Date: February 2, 2026
Company: B Braun Medical Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B Braun Medical Inc directly.

Affected Products

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

Quantity: 105550 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B Braun Medical Inc

B Braun Medical Inc has 148 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report