TruDi¿ Navigation System — Class II medical device recall Z-0420-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2025-11-12, distributed nationwide. It was determined that when the navigation system is configured with specific revision combinations of the Mul
| Recall number | Z-0420-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2025-10-03 |
| Classified | 2025-11-04 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,198 units |
| UPC / GTIN / UDI-DI | 10846835021103 |
| Model numbers | 10846835021103, EM-2025-000F |
Product
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0420-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.