FDA-Device2026-03-11Class IIPROCESSING DEFECT
B. Braun 21GA winged infusion needle recalled for dull or broken needle tip
OTHERNationwide distribution
Stop using B. Braun infusion needles (Model 7A3842)
B. Braun Medical Inc is recalling certain 21-gauge winged infusion needles used to expand tissue expanders. The needle tips may be dull, blunt, or break during use, which could make the device difficult or impossible to use properly.
- Check your supply for the recalled lots: 0062004706, 0062005799, 0062006415, 0062006416, 0062023397, or 0062024887.
- Stop using any affected needles immediately.
- Contact your supplier or B. Braun Medical Inc for instructions on replacement or return.
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
21000 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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-1482-2026More B Braun Medical Inc recalls
- FDA-Device2026-04-22B. Braun StreamLine Bloodline hemodialysis tubing recalled for air bubble accumulation risk
- FDA-Device2026-04-22B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis
- 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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