Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System
- Recalling company
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
- Reason
- It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 3, 2025
- Reported
- Nov 12, 2025
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 1198 units
- Lot / codes
- Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0420-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0420-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.