FDA Device recall Z-0504-2026
BD Luer Tip Caps
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of BD Luer Tip Caps by Becton Dickinson And, citing BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0504-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-14 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Reason
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Identifiers
| code_info | Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0504-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.