FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
OTHERNationwide distribution
Halyard Eye Bag Pack recalled for sterilization failure
AVID Medical, Inc. distributed 60 kits of Halyard Eye Bag Pack (Kit Code UIEB48-01) with sealed pouches that did not undergo validated sterilization. The affected kits were distributed nationwide in Iowa. No injuries have been reported.
- Check if you have Kit Code UIEB48-01 with lot number UIEB48-01 and expiration date 8/7/2028.
- Stop using the product and contact AVID Medical, Inc. or your supplier for instructions on return or replacement.
- Do not use non-sterilized medical pouches.
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Sold states
US Nationwide distribution in the state of Iowa.
Affected count
60 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2410-2026More AVID Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
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