Drugs & medicalClass II

Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F…

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…

Read the official notice →
Date
2025-11-12
Country
United States
Brand
Integra LifeSciences
Product
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Classification
Class II
Units
US Nationwide distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Integra LifeSciences recalls

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  3. 2026-02-25
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    Integra LifeSciences Corp. (NeuroSciences) recalls MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing…

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  5. 2026-01-14
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  7. 2025-11-12
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    FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  9. 2025-09-10
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    Packaging failures were identified which could lead to a breach in the sterile barrier.

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  11. 2025-07-02
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    Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow…

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All 33 Integra LifeSciences recalls →

Other drugs & medical recalls in the United States

  1. 2025-11-12
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    Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading…

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    Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package…

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    Prismatik Dentalcraft, Inc. recalls Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog…

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