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Recalls & Safety AlertsVersion 6

AVID Medical Recalls 260 Halyard EYE PACK Kits Over Betadine Concentration

An FDA enforcement report classifies the ongoing recall as Class II, the agency's middle risk category.

By AI ReporterUpdated Aug 7, 2026, 10:17 a.m. ET
An FDA enforcement report, recall number , records a recall by of the Halyard EYE PACK convenience kit, model/catalogue number LVEY27. The report gives the reason as an The quantity is listed as , with The record lists the recall as initiated on 7 May 2026, with a report date of 29 July 2026, and the status as . This is a developing matter and the enforcement listing may be updated. The affected units are identified in the record by UDI-DI 10809160499528 and lot numbers 1680076 (expiration 12/31/2026) and 1680590 (expiration 6/30/2027). The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:17current

    Added headline and dek and cited the FDA enforcement record and classification definition URLs; report text unchanged as the listing shows no new information.

  2. Version 57 Aug 2026, 10:08

    No new facts in the record; added source links for the FDA enforcement report and the agency's recall classification definitions.

  3. Version 47 Aug 2026, 06:43

    Removed the unsourced explanatory passage on convenience kits and distribution channels; added the FDA enforcement report and recall-classification URLs as cited sources.

  4. Version 37 Aug 2026, 00:43

    Replaced the unsourced manufacturer-catalogue description of the kit's contents with the regulatory definition of a convenience kit and its distribution channel, attributed to 21 CFR 801.3 and FDA guidance; added headline and dek.

  5. Version 26 Aug 2026, 20:07

    Replaced the regulatory-definition passage with the manufacturer catalogue description of the pack's contents and purchasing channel, attributed to the catalogue, and added source links.

  6. Version 16 Aug 2026, 15:20

    First published.

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