Official recall notice
FDA DeviceClass IINotable
Craniotomy Pack Recall (Oct 2026) – AVID Medical
Product: CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
- 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): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943; Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;