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

Lot, batch or date codesModel/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).
Quantity recalled260 kits

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
E-Mail
Reason category
Other Reasons

Timeline

7 May 2026Recall initiated by company
20 Jul 2026Classified by FDA+74 days
29 Jul 2026Published 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.

Nationwide 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.

More recalls from Avid Medical

All 184

Other Other Medical Devices recalls

All 13,778