FDA-Device2026-01-14Class IPROCESSING DEFECT
Halyard ORGAN RECOVERY OR PACK recalled as unsuitable for organ transplant
What this means
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
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
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 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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