FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
- Recall number
- Z-2763-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
- Status
- Open, Classified
- Initiated
- 2026-05-07
- Posted
- 2026-07-20
- Terminated
- not on file
- Reason
- Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 260 kits
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJK
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28