FDA-Device2026-01-14Class IMISBRANDING
Halyard MINI PLUS KIT SOUTH recalled—not suitable for organ transplant
FALSE CLAIMSNationwide distribution
Do not use Halyard MINI PLUS KIT SOUTH
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.
Hazard
Devices are not suitable for organ transplant.
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, 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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