Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A
Summary
The FDA issued a Class II for Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catal by B Braun Medical Inc. Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break..
Details
Source
Device Recall
External ID
Z-1482-2026
Action Date
2026-03-11
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 21000 units
Reason for Recall
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-02
Company
Bethlehem, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B Braun Medical Inc have FDA actions?
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1482-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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