CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Halyard Lavh Pack recalled by AVID Medical
Avid Medical is recalling Halyard Lavh Pack, distributed nationwide in the US. The recall was initiated on 10 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2964-2026
- FDA event ID
- 99443
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +35 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Where it was distributed
US Nationwide distribution in the state of TX.
Questions about this recall
Why was it recalled?
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Which lots are affected?
UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
Where was it sold?
US Nationwide distribution in the state of TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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