Halyard Davinci TruCustom Foley Tray
Halyard Davinci TruCustom Foley tray recalled over missing latex warning on StatLock component.
If you have this kit, stop using it and contact AVID Medical, Inc. for a replacement or further instructions.
Why it was recalled
AVID Medical, Inc. is recalling Halyard Davinci TruCustom bundles containing a Foley 16FR tray with a StatLock component due to a labeling deficiency. The kit labeling fails to identify that the StatLock component contains natural rubber latex, posing a risk of allergic reaction to latex-sensitive individuals.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI | Model/Catalog number |
|---|---|---|---|---|
| Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | 1649519 | Z-3006-2026 | 10809160423578 | – |
| Halyard DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK | 1634391 | Z-3005-2026 | 10809160439708 | SAMM064-27 |
| Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | 1649519 | Z-3009-2026 | 10809160457887 | – |
| Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | 1649519 | Z-3007-2026 | 10809160457887 | – |
| Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | 1649519 | Z-3010-2026 | 10809160457887 | – |
| Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | 1649519 | Z-3008-2026 | 10809160457887 | – |
| Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | 1649519 | Z-3011-2026 | 10809160457887 | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Labeling Error recalls
Other recent recalls from AVID Medical, Inc.
Editorial summary by Recall Canary · summary updated 2026-08-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification