Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842...

FDA Device Recall #Z-1482-2026 — Class II — February 2, 2026

Recall Summary

Recall Number Z-1482-2026
Classification Class II — Moderate risk
Date Initiated February 2, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B Braun Medical Inc
Location Bethlehem, PA
Product Type Devices
Quantity 21000 units

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

Reason for Recall

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

Distribution Pattern

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

Lot / Code Information

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

Other Recalls from B Braun Medical Inc

Recall # Classification Product Date
Z-2278-2026 Class I Design Options Spinal Tray Spinal Needle Anesth... May 6, 2026
Z-2277-2026 Class I Spinocan Spinal Needle procedure kits: Materi... May 6, 2026
Z-2276-2026 Class I Spinal Needle procedure kits: Material Descri... May 6, 2026
Z-1803-2026 Class I B Braun Hemodialysis Bloodlines, LOW VOL, NO CH... Mar 19, 2026
Z-1798-2026 Class I B. Braun Hemodialysis Bloodlines, STREAMLINE BL... Mar 19, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.