The Recall Desk

Hazard

Surgical Guidance Error recalls

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

What the numbers show

Total
3
Critical
1
Severe
0
Most recent
2024-07-24

Of the 3 surgical guidance error recalls we have scored against our rubric, 1 (33%) 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 surgical guidance 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.

1–3 of 3

  • HighFDA (Devices)·Z-2412-2024·2024-07-24

    Surgical Image Guidance Software May Cause Incorrect Toric IOL Axis Placement

    Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.

    Product
    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2023·2023-10-04

    exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning

    Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.

    Product
    exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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