TemporaryFDAOngoing
Can cause harm that is usually temporary.
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Check the device or its packaging for
UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
- Why
- The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Distributed
- US Nationwide distribution in the state of TX.
- Company
- AVID Medical, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2964-2026 · retrieved 14 August 2026
Read the official notice