Reported Nov 12, 2025 · Ongoing
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev…
Integra LifeSciences Corp. (NeuroSciences)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. (NeuroSciences) · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's
- Product Number (Catalog Number)EM-2025-000F Rev 00 or Rev 01
- Lot codes and dates
- Manufacturer's
- Product Number (Catalog Number)EM-2025-000F Rev 00 or Rev 01
- UDI-DI10846835021103
- Amount recalled
- 1198 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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