FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
What this means
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.
The agency's original wording
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-09-09Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
- FDA-Device2026-07-29Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
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