FDA DevicesClass II
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/...
Published: March 11, 2026Recall ID: Z-1481-2026Category: devicesCountry: US
Reason for Recall / Hazard
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Bethlehem |
| State | PA |
| Event id | 98380 |
| Address 1 | 824 12th Ave |
| Address 2 | N/A |
| Code info | 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. |
| Postal code | 18018-3524 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 105550 units |
| Reason for recall | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260202 |
| Initial firm notification | Letter |
| Center classification date | 20260302 |
Overview
- Recalling FirmB Braun Medical Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.