FDA Device recall Z-0927-2026
Halyard, EP LAB PK. Catalog Number: ESJH009-03
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of Halyard, EP LAB PK. Catalog Number: ESJH009-03 by Avid Medical, citing potential for incomplete seal on header bag.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0927-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-14 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | GA, IL, MD, NE |
Product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Reason
Potential for incomplete seal on header bag.
Identifiers
| code_info | Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028. |
|---|
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-0927-2026%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.