Official recall notice
FDA DeviceClass IINotable
Davinci Trucustom Bundle Recall (Oct 2026) – AVID Medical
Product: DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
- Recall date
- 2026-10-14
- Brand
- AVID Medical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Product description
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Affected products
1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251; 2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700; Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359;