CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Halyard EYE PACK recalled by AVID Medical
Avid Medical is recalling Halyard EYE PACK, distributed nationwide in the US. The recall was initiated on 7 May 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-2763-2026
- FDA event ID
- 99249
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2026
- FDA classified
- 20 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 May 2026 | Recall initiated by company | |
| 20 Jul 2026 | Classified by FDA | +74 days |
| 29 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Product as listed by the FDA
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Why was it recalled?
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Which lots are affected?
Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).
Where was it sold?
US Nationwide distribution in the state of California.
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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