Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY... recall (AVID Medical, Inc.)
Medical deviceClass IIOngoing
Summary: AVID Medical, Inc. is recalling Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27. Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
What is being recalled
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Why
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MS, TX. (states named: Mississippi, Texas)
How to tell if yours is affected
Lot Code: Lot Number: 1634391 UDI: 10809160439708
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3005-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 9, 2026 |
| Reported | September 2, 2026 |
| Company | AVID Medical, Inc. |
| Company location | Toano, VA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 45 kits |
More recalls from AVID Medical, Inc. · all medical device recalls · recalls from July 2026