FDA-Device2026-01-14Class IMISBRANDING
Halyard MINI PLUS KIT SOUTH recalled—not suitable for organ transplant
What this means
AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.
- Stop using this kit immediately if you have it in your facility.
- Check your inventory for Kit Code JACK097-08 and Lot No. 1654185.
- Contact your supplier or AVID Medical for instructions on return or replacement.
- If this kit was already used in an organ transplant procedure, contact your medical director or the FDA.
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
380 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1002-2026More 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.