FDA Medical devices recall ·
TruDi¿ Navigation System - Multi Instrument Adapter recall
- Recall number
- Z-0420-2026
- Date
- (initiated October 3, 2025)
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1198 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0420-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.