FDA Device recall Z-1338-2026
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01 by Avid Medical, citing tyvek bag seal issue which may compromise sterility of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1338-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-02 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Reason
Tyvek bag seal issue which may compromise sterility of the kit.
Identifiers
| code_info | Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1338-2026%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.