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Home › FDA recalls › Brand Name: B. Braun Product Name: 21GA WINGED INFUSION
CLASS II · ModerateFDA

B Braun Medical Inc recalls Brand Name: B. Braun Product Name: 21GA WINGED INFUSION

📅 Feb 2, 2026 · 📍 Nationwide
Recalling company
B Braun Medical Inc
Product
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
Reason
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 2, 2026
Reported
Mar 11, 2026
Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Status
Ongoing
Quantity
21000 units
Lot / codes
Model/Catalog Number: 7A3842; Primary-DI 4046964338434; Unit of Use- DI 4046964338410; Lot 0062004706, Exp 31MAR2032; Lot 0062005799, Exp 30JUN2032; Lot 0062006415, Exp 31MAR2032; Lot 0062006416, Exp 31MAR2032; Lot 0062023397, Exp 30JUN2032; Lot 0062024887, Exp 31JUL2032
Company location
Bethlehem, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-1482-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1482-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.