Z-2763-2026Class II

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

Name: Z-2763-2026 Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit
Creator: AVID Medical, Inc.
Published: 2026-05-07
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-05-07 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit on 2026-05-07. FDA classified it as Class II and gives the reason as "Incorrect concentration of Betadine solution contained within certain AVID convenience kits". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2763-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-07
Posted: 2026-07-20
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Product code: OJK Eye Tray
Reason for recall: Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Root cause tag: manufacturing process
FDA 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 in commerce: 260 kits
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2763-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2763-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-20

Product code OJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)