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Halyard EYE PACK. Model/Catalog Number: LVEY27 recallZ-2763-2026 · AVID Medical, Inc. · initiated May 7, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2763-2026
Status
Open, Classified
Initiated by the company
May 7, 2026
Posted by the FDA
Jul 20, 2026
Recalling firm
AVID Medical, Inc.
Quantity
260 kits
Product code
OJK
Distribution
US Nationwide distribution in the state of California.

Product description

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

Code information (models, lots, serial numbers)

Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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