FDA Device recall Z-2530-2025
Halyard, ENT PACK. Model Number: JACK421-04
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Halyard, ENT PACK. Model Number: JACK421-04 by Avid Medical, citing potential for open header bag seals, compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2530-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-04 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Reason
Potential for open header bag seals, compromising sterility.
Identifiers
| code_info | Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027. |
|---|
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-2530-2025%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.