FDA recall, , Moderate risk
AVID Medical Halyard LAVH Packs
The Halyard Lavh Pack with Clearify Visualization System may leak because the component was sterilized against manufacturer recommendation.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc., of Toano, Virginia, recalled 40 Halyard LAVH PACKs containing the Clearify Visualization System (5303907). A customer complaint reported that the Clearify Visualization System leaked in a kit. Avid's investigation determined that the component was subjected to EO sterilization, which is not in alignment with the manufacturer's recommendation, and may have led to the component leaking.
The recall began on July 10, 2026, and was added to the FDA's Enforcement Report on August 14, 2026. The packs were distributed in Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Halyard LAVH Pack
- Model number
- /Catalog Number: USAR053-11
- USAR053-11
- UDI-DI
- 10809160372357
- Lot code
- 1669869
Clearify Visualization System
- Model number
- 5303907
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Texas.
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99443
- Recall number
- Z-2964-2026
- Quantity recalled
- 40 packs
All recalls from AVID Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
