FDA-Device2026-01-14Class IPROCESSING DEFECT
Halyard ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) recalled as unsuitable for organ transplant
What this means
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
The agency's original wording
Hazard
Devices are not suitable for organ transplant.
Intended for
Adults
Illnesses reported
None reported
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 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
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