FDA recall, , Moderate risk
Halyard Total Joint and DaVinci TruCustom Bundles
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc. of Toano, Virginia recalled Halyard Total Joint kits and Davinci Trucustom Bundle kits containing Tray Foley 16FR W/Statlock because the medical kit labeling fails to identify that the statlock component contains natural rubber latex. The recall began July 9, 2026, and was added to the FDA's Enforcement Report on August 21, 2026. The products were distributed in Mississippi and Texas.
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 your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
Halyard Total Joint Model/
- Catalog code
- MSBM036-03
- UDI-DI
- 10809160423578
- Lot code
- 1632948
- UDI-DI
- 10809160457887
- Lot code
- 1662335
- UDI-DI
- 10809160457887
- Lot code
- 1649979
- UDI-DI
- 10809160457887
- Lot code
- 1673233
- UDI-DI
- 10809160457887
- Lot code
- 1654575
- UDI-DI
- 10809160457887
- Lot code
- 1649519
Halyard DaVinci TruCustom Bundle Containing Tray Foley 16FR W/Statlock
- UDI-DI
- 10809160439708
- Model/Catalog number
- SAMM064-27
- Lot code
- 1634391
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Mississippi, Texas.
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Labeling error
- 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
- 99527
- Recall numbers
- Z-3005-2026 to Z-3011-2026
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
