The Recall Desk

Hazard

Navigation Error recalls

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

What the numbers show

Total
11
Critical
0
Severe
1
Most recent
2026-04-08

Of the 11 navigation error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (9%) 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 navigation error 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.

1–11 of 11

  • HighFDA (Devices)·Z-1735-2026·2026-04-08

    Civco eTRAX 12G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1736-2026·2026-04-08

    Civco eTRAX 14G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1734-2026·2026-04-08

    Civco eTRAX 18G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1737-2026·2026-04-08

    Civco eTRAX needle sensor may misreport needle tip position onscreen

    Civco is recalling the eTRAX Needle Sensor 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified on the user interface.

    Product
    eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1731-2026·2026-04-08

    Civco eTRAX 12G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1733-2026·2026-04-08

    Civco eTRAX needle starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1738-2026·2026-04-08

    Civco eTRAX 18G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1732-2026·2026-04-08

    Civco eTRAX 14G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1590-2026·2026-04-01

    GE Imactis CT navigation may show needle trajectory that differs from actual

    GE Medical Systems is recalling the Imactis CT-Navigation System because of a potential discordance between the simulated needle trajectory and tip position and the actual trajectory and tip position.

    Product
    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2024·2023-11-15

    StealthStation S8 Surgical Navigation System Software Anomaly Recall

    Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.

    Product
    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2972-2020·2020-09-23

    Imactis Patient Fiducial Recalled Due to Component Separation Risk

    Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.

    Product
    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
    Category
    Medical Device
    Distribution
    Distributed nationwide