FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
OTHERNationwide distribution
Halyard Drape Pack recalled for unsterilized pouches
Halyard Drape Pack kits (Code LMDP36-01) were distributed without proper sterilization validation. Approximately 72 kits shipped with sealed pouches that had not undergone the required sterilization process. These kits were distributed nationwide and in Iowa.
- Check if you have Halyard Drape Pack Kit Code LMDP36-01, Lot LMDP36-01, with expiration 9/10/2028
- Do not use affected kits for sterile procedures
- Contact AVID Medical, Inc. or your supplier for return or replacement instructions
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Sold states
US Nationwide distribution in the state of Iowa.
Affected count
72 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard, Drape Pack. Kit Code: LMDP36-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2026More 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 Eye Bag Pack recalled for non-sterilized sealed pouches
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