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Home › FDA recalls › Halyard LAVH PACK
CLASS II · ModerateFDA

AVID Medical, Inc. recalls Halyard LAVH PACK

📅 Jul 10, 2026 · 📍 Nationwide
Recalling company
AVID Medical, Inc.
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 10, 2026
Reported
Aug 26, 2026
Distribution
US Nationwide distribution in the state of TX.
Status
Ongoing
Quantity
40 packs
Lot / codes
UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
Company location
Toano, VA
Recall type
Voluntary: Firm initiated
Recall number
Z-2964-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2964-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.