Atlas FDA

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

FDA device recall Z-2763-2026 · posted 2026-07-20 · Open, Classified

Recall details

Recalling firm
AVID Medical, Inc.
Reason for recall
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Action taken
AVID 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, to ensure all end-users are appropriately notified and maintain records of effectiveness. Recipients were requested to complete and return the provided Recall Response Form by 05/22/2026.
Root cause
Process control
Status
Open, Classified
Product code
OJK
Quantity affected
260 kits
Distribution
US Nationwide distribution in the state of California.
Date initiated
2026-05-07
Date posted
2026-07-20
Location
Toano, VA

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