FDA Device recall Z-1743-2025
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit by Avid Medical, citing an issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1743-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-31 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Reason
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Identifiers
| code_info | Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1743-2025%22
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