Official recall notice
FDA DeviceClass IINotable
Heart Prep Tray Recall (Oct 2026) – AVID Medical
Product: HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
- 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
Model/Item Number (Kit): MECV97W; UDI-DI: 10809160493113; Kit Lot Numbers: 1691836, 1696316; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKV2393;