Recall Z-2763-2026
AVID Medical, Inc. · initiated May 7, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Codes / lots: Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).
Reason for recall
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2763-2026
- Initiated
- May 7, 2026
- Posted by FDA
- July 20, 2026
- Product code
- OJK – Eye Tray
- Quantity
- 260 kits
- Distribution
- US Nationwide distribution in the state of California.
- Recalling firm
- AVID Medical, Inc., Toano, VA