ClearanceBrief
Recall Z-2763-2026 ยท OJK Eye Tray

AVID Medical, Inc.

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

DateJul 20, 2026 (initiated May 7, 2026)
StatusOpen, Classified
ReasonIncorrect concentration of Betadine solution contained within certain AVID convenience kits.
Root causeProcess control
ActionAVID Medical notified the single consignee on about 05/07/2026 via email. The consignee was instructed to identify, segregate, and quarantine all impacted products, add the provided warning labels to affected AVID kits to ensure all users are aware of the issue, and discard all impacted components upon opening the Eye Pack. Customers and end users were instructed that if they received affected products from a distributor, to please contact that distributor of sales representatives with questions. Distributors were instructed that if any of the affected kits identified were further distributed,
Quantity260 kits
DistributionUS Nationwide distribution in the state of California.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.