FDA-Device2026-01-14Class IPROCESSING DEFECT
Halyard ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) recalled as unsuitable for organ transplant
OTHERNationwide distribution
Do not use Halyard ORGAN RECOVERY OR PACK
Halyard's ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) is not suitable for organ transplant procedures. The FDA has classified this as a Class I recall, the most serious type. A total of 52 units were distributed in Florida, Georgia, and Puerto Rico.
- Stop using Kit Code LLOF1000-17 immediately if you have it in your facility
- Contact your supplier or Halyard for instructions on return or disposal
- Verify the kit code and UDI (10809160460726) or lot number (1651709) before use
- Notify your transplant team or procurement coordinator if you received this kit
Hazard
Devices are not suitable for organ transplant.
Sold states
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Affected count
52 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2026More 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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