FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Pain Pack Kit recalled for unsterilized pouches
OTHERNationwide distribution
Halyard Pain Pack Kit recalled for unsterilized pouches
AVID Medical distributed 120 sealed Halyard Pain Pack kits (Kit Code AMPK48-01, Lot 334669) that did not undergo proper sterilization validation. The affected kits were distributed nationwide, with known distribution in Iowa. No injuries have been reported.
- Check if you have Halyard Pain Pack Kit Code AMPK48-01, Lot 334669 (Expiration 8/27/2028).
- Do not use affected kits.
- Contact your distributor or AVID Medical for instructions on return or replacement.
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Sold states
US Nationwide distribution in the state of Iowa.
Affected count
120 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard, Pain Pack. Kit Code: AMPK48-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2407-2026More AVID Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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