CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report
TruDi¿ Navigation System - Multi Instrument Adapter recalled
Integra LifeSciences Corp. (NeuroSciences) is recalling TruDi¿ Navigation System - Multi Instrument Adapter, distributed nationwide in the US. The recall was initiated on 3 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0420-2026
- FDA event ID
- 97677
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2025
- FDA classified
- 4 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Oct 2025 | Recall initiated by company | |
| 4 Nov 2025 | Classified by FDA | +32 days |
| 12 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Integra LifeSciences Corp. (NeuroSciences)
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OmniTract Surgical Retractor System recalled | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide |
| Device | CLASS II | Codman CerebroFlo EVD Catheter with Endexo Technology recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Device Malfunction | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |