AVID Medical, Inc. recalls Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Reason for recall
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kitUDI-DI 10809160499528.Catalog # Number2 affected lots16800761680590
What the firm 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.
DistributionShow detailsHide
US Nationwide distribution in the state of California.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2763-2026
- FDA device classification · OJKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.4790The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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