Class II — AVID Medical, Inc.
| Recalling firm | AVID Medical, Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907). |
| Quantity | 40 packs |
| Distribution | US Nationwide distribution in the state of TX. |
| Initiated | 2026-07-10 |
| Classified | 2026-08-14 |
| Recall number | Z-2964-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AVID Medical, Inc. (Z-2964-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99443/
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