FDA-Device2026-03-11Class IIPROCESSING DEFECT
B. Braun tissue expander injection needle recalled for dull or broken tip
OTHERNationwide distribution
Stop using B. Braun 21G injection needles
B. Braun's 21G winged injection needles used for tissue expander procedures may have dull, blunt, or broken needle tips. This can make the needle difficult to advance during use. The issue affects specific lot numbers with expiration dates through September 2032.
- Check your supply for affected lot numbers (0062006430, 0062006470, 0062006471, 0062014964, 0062014965, 0062014966, 0062027579)
- Do not use needles with dull or damaged tips
- Contact B. Braun Medical Inc or your supplier for replacement or instructions
- Report any needle breakage or difficulty during use to FDA MedWatch
Hazard
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Sold states
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Affected count
105550 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1481-2026More B Braun Medical Inc recalls
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- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
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