FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Towel Six Pack recalled for non-sterilized sealed pouches
What this means
AVID Medical inadvertently distributed 224 kits of Halyard Towel Six Pack (Kit Code AMTS70-01) with sealed pouches that had not undergone validated sterilization. The affected kits were distributed nationwide, with concentration in Iowa. No injuries have been reported.
- Check your Halyard Towel Six Pack kit for Kit Code AMTS70-01 and Lot Number AMTS70-01.
- Do not use pouches from affected kits in sterile field applications.
- Contact your supplier or AVID Medical for instructions on return or replacement.
The agency's original wording
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Iowa.
Affected count
224 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2408-2026More 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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