The Recall Desk

Hazard

Inaccurate Navigation recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
1
Severe
2
Most recent
2023-06-14

Of the 5 inaccurate navigation recalls we have scored against our rubric, 1 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate navigation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • CriticalFDA (Devices)·Z-1666-2023·2023-06-14

    StealthStation Cranial Software displays inaccurate navigation during brain surgery

    A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.

    Product
    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1693-2020·2020-04-22

    Medtronic NavLock Tracker Recalled Due to Incorrect Assembly

    Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.

    Product
    NavLock Tracker *** Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0598-2016·2016-01-27

    Brainlab Cranial Navigation System Recalled for Potential Software Inaccuracy

    Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.

    Product
    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2325-2015·2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2324-2015·2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide