FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
What this means
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
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
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 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.