FDA Device recall Z-2964-2026
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907)
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907) by Avid Medical, citing the kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2964-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-10 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Reason
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Identifiers
| code_info | UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Avid Medical
- GYN LAPAROSCOPY/LAPAROTOMY
FDA Device · Class II · 2026-10-14 · Avid Medical - LAPAROSCOPIC PROSTATECTOMY
FDA Device · Class II · 2026-10-14 · Avid Medical - GYN LAPAROSCOPY PACK
FDA Device · Class II · 2026-10-14 · Avid Medical - ABD HYSTERECTOMY
FDA Device · Class II · 2026-10-14 · Avid Medical - CRANIOTOMY PACK
FDA Device · Class II · 2026-10-14 · Avid Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2964-2026%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.