Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7...
FDA Device Recall #Z-1481-2026 — Class II — February 2, 2026
Recall Summary
| Recall Number | Z-1481-2026 |
| 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 | 105550 units |
Product Description
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 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: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.
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.