Lower riskMedical device recall · FDA · Published October 3, 2025
Integra TruDi Navigation System Multi Adapter Recall: Accuracy Issues
Integra LifeSciences recalls TruDi Navigation System Multi Instrument Adapters (EM-2025-000F Rev 00/01) due to potential accuracy problems during patient anatomy verification. Affected users should contact for details.
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.
Integra LifeSciences is recalling its TruDi Navigation System Multi Instrument Adapters (model EM-2025-000F Rev 00 or 01) because they may not work accurately when used with certain patient trackers. This could lead to incorrect visual verification of device location in patients. Read more at govinfonow.com/recall/51116-integra-trudi-navigation-system-multi-adapter-recall-accuracy-issues.
“Integra TruDi Navigation System Multi Adapter Recall: Accuracy Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51116-integra-trudi-navigation-system-multi-adapter-recall-accuracy-issues. Based on FDA recall #Z-0420-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2026%22&limit=1).
Integra LifeSciences Corp. (NeuroSciences) voluntarily recalled its TruDi¿ Navigation System Multi Instrument Adapter on Oct. 3, 2025, according to the FDA. The device may not meet specified accuracy for visual verification of device location within a patient's anatomy.
How to tell if you have it
Brand: Integra LifeSciences
Product: TruDi¿ Navigation System - Multi Instrument Adapter
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01
UDI-DI: 10846835021103
Units affected: 1198
The hazard
The FDA said the navigation system may not meet its specified accuracy for visual verification of device location within the patient's anatomy when configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker.
Context
GovInfoNow's records show Integra LifeSciences Corp. (NeuroSciences) has 12 other recalls on record since April 4, 2025. Other recent recalls include the Integra Cytal Wound Matrix 2-Layer 7x10 cm recall on March 19, 2026, and the Codman CerebroFlo EVD Catheter recall on April 10, 2026. Similar product recalls include the Civco eTRAX Needle Sensor recall on March 2, 2026, and the GE Medical Systems Imactis CT-Navigation System recall on Feb. 3, 2026.
How to tell if you have this one
Check for the manufacturer's product number EM-2025-000F Rev 00 or Rev 01 on the adapter. The recall applies to devices sold with this specific model number.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number on the adapter to confirm if it is EM-2025-000F Rev 00 or Rev 01.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0420-2026 (October 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0420-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.