Recall Z-2964-2026— AVID Medical, Inc.

Name: FDA recall Z-2964-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2026-07-10. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-10
Firm location: Toano, VA, United States

Product description

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

Reason for recall

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Data sourced from openFDA. This site is unofficial and independent of the FDA.