Recall Ledger

Brand Name: B. Braun Product Name: 21GA WINGED INFUSION recall (B Braun Medical Inc)

Medical deviceClass IIOngoing

Summary: B Braun Medical Inc is recalling 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 o. Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

What is being recalled

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

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. (states named: Texas)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1482-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedFebruary 2, 2026
ReportedMarch 11, 2026
CompanyB Braun Medical Inc
Company locationBethlehem, PA, United States
Initiated byVoluntary: Firm initiated
Quantity21000 units

More recalls from B Braun Medical Inc · all medical device recalls · recalls from February 2026

Official FDA record