Recall Z-1481-2026— B Braun Medical Inc
Class II · Ongoing
Class II FDA medical device recall by B Braun Medical Inc, initiated 2026-02-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break..
- Recalling firm
- B Braun Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-02
- Firm location
- Bethlehem, PA, United States
Product description
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
Reason for recall
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Data sourced from openFDA. This site is unofficial and independent of the FDA.