Integra LifeSciences Corp. (NeuroSciences): Device Recall

Recall #Z-0420-2026 · 10/03/2025

Class II: Risk

Recall Details

Recall Number: Z-0420-2026
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp. (NeuroSciences)
Status: Ongoing
Date Initiated: 10/03/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1198 units

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.

Product Description

TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;

Distribution Pattern

US Nationwide distribution.

Other Recalls by Integra LifeSciences Corp. (NeuroSciences)

Class II: Risk 12/12/2025

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II: Risk 12/12/2025

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class I: Dangerous 09/26/2025

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class I: Dangerous 09/26/2025

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class II: Risk 08/05/2025

Packaging failures were identified which could lead to a breach in the sterile barrier.

View all recalls by Integra LifeSciences Corp. (NeuroSciences) →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.