The Recall Desk

Hazard

Incorrect Biopsy recalls

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

What the numbers show

Total
2
Critical
1
Severe
0
Most recent
2019-01-09

Of the 2 incorrect biopsy recalls we have scored against our rubric, 1 (50%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 incorrect biopsy 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.

1–2 of 2

  • CriticalFDA (Devices)·Z-0552-2019·2019-01-09

    Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error

    Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.

    Product
    StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2871-2016·2016-09-28

    Merge Healthcare Recalls CADstream MRI Software Due to Grid Selection Error

    Merge Healthcare is recalling CADstream software versions 4.1.3 and prior because an incorrect grid selection could lead to an incorrect biopsy or missed target during MRI analysis.

    Product
    CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tool
    Category
    Medical Device
    Distribution
    Distributed nationwide