Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
FDA device recall Z-2410-2026 · posted 2026-06-11 · Open, Classified
Recall details
- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
- Action taken
- AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OJH
- Quantity affected
- 60 kits
- Distribution
- US Nationwide distribution in the state of Iowa.
- Date initiated
- 2026-04-30
- Date posted
- 2026-06-11
- Location
- Toano, VA
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