BD Luer Tip Caps — Class II medical device recall Z-0504-2026
Ongoing recall by Becton Dickinson & Company, reported 2025-11-26, distributed nationwide. BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
| Recall number | Z-0504-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2025-10-14 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, SG |
| Quantity | 4,180,000 units |
| UPC / GTIN / UDI-DI | 50382903083416 |
| Lot numbers | 5029670, 5034211, 5041975 |
| Model numbers | 308341, 5029670, 5034211, 50382903083416, 5041975 |
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Reason for recall
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
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-0504-2026. 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.