Brand Name: B — Class II medical device recall Z-1481-2026
Ongoing recall by B Braun Medical Inc, reported 2026-03-11, distributed nationwide. The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
| Recall number | Z-1481-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2026-02-02 |
| Classified | 2026-03-02 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR |
| Quantity | 105,550 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046964341274, 04046964341298 |
| Lot numbers | 0062006430, 0062006470, 0062006471, 0062014964, 0062014965, 0062014966, 0062027579 |
| Model numbers | 7B3050 |
| Expiration dates | 2032-04-30, 2032-05-31, 2032-06-30, 2032-07-31, 2032-08-31, 2032-09-30 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1481-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.