FDA recall, , Moderate risk
Halyard Transport Bag Kit
The Halyard TRANSPORT BAG KIT has a Tyvek bag seal issue that may compromise sterility.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc. of Toano, Virginia recalled the Halyard Transport Bag Kit, Kit Code LIFE0080-01, because of a Tyvek bag seal issue that may compromise sterility of the kit. The company began the recall on January 2, 2026, and the FDA added it to its Enforcement Report on February 9, 2026. The recall involved 1,500 units distributed nationwide in the United States, including New Jersey.
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 yours affected?
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 Transport Bag Kit. Kit Code: LIFE0080-01.
- UDI-DI
- 10809160314500
- Lot code
- 1650056
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of New Jersey.
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98298
- Recall number
- Z-1338-2026
- Quantity recalled
- 1,500 units
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
Summary updated
