FDA recall, , High risk
Halyard Organ Recovery OR Pack and Mini Plus Kit South
Halyard Organ Recovery OR Pack and Halyard Mini Plus Kit South are not suitable for organ transplant.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc. of Toano, Virginia began a recall on November 11, 2025, for Halyard Organ Recovery OR Pack and Halyard Mini Plus Kit South because the devices are not suitable for organ transplant. The FDA added the recall to its Enforcement Report and classified it on January 2, 2026, and it was in the weekly enforcement report on January 14, 2026. Distribution was in the states of FL, GA and Puerto Rico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
3 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Halyard Organ Recovery OR Pack, Kit Code: LLOF1000-17.
- UDI-DI
- 10809160460726
- Lot code
- 1651709
Halyard Mini Plus Kit South, Kit Code: JACK097-08
- UDI-DI
- 10809160462829
- Lot code
- 1654185
Halyard Organ Recovery OR Pack, Kit Code: LLOG1000-15.
- UDI-DI
- 10809160432679
- Lot code
- 1632138
- 1648393
Recall details
- Company began the recall
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98060
- Recall numbers
- Z-1000-2026 to Z-1002-2026
All recalls from AVID Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
