FDA-Device2026-01-14Class IPROCESSING DEFECT
Halyard ORGAN RECOVERY OR PACK recalled as unsuitable for organ transplant
OTHERNationwide distribution
Stop using Halyard ORGAN RECOVERY OR PACK
Halyard ORGAN RECOVERY OR PACK (Kit Code LLOG1000-15) devices have been found to be unsuitable for organ transplant use. The FDA has issued a Class I recall affecting 132 units distributed in Florida, Georgia, and Puerto Rico. No injuries have been reported.
- Stop using affected kits immediately if your facility has Lot No. 1632138 or 1648393
- Contact your supplier or Halyard Medical for instructions on return or disposal
- Verify your kit's lot number against the recall notice before use
Hazard
Devices are not suitable for organ transplant.
Sold states
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Affected count
132 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1000-2026More 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 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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