The Recall Desk

Hazard

Diagnostic Error Risk recalls

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

What the numbers show

Total
12
Critical
0
Severe
1
Most recent
2026-05-06

Of the 12 diagnostic error risk 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 (8%) 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 diagnostic error risk 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.

1–12 of 12

  • SevereFDA (Devices)·Z-1984-2026·2026-05-06

    Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination

    Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.

    Product
    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2025·2025-03-26

    VERICIS Merge Cardio Cardiovascular System Software Recall for Measurement Inconsistency

    Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final patient reports.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0600-2025·2024-12-11

    GE Healthcare CT Systems May Display Rotated Images in Diagnostic Scans

    Certain GE Healthcare CT systems may produce progressively rotated images during diagnostic scans. If undetected and a rescan is needed, the same rotation recurs.

    Product
    GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0105-2025·2024-10-23

    Boston Scientific AVVIGO+ Multi-Modality Guidance System Grid Display Software Defect

    Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2024·2024-06-05

    FDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment

    The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.

    Product
    Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2023·2023-07-19

    Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.

    Product
    COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2022·2022-08-31

    GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport

    GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.

    Product
    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1232-2022·2022-06-15

    Centricity Cardiology CA1000 may display inaccurate distance and area measurements

    GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.

    Product
    Centricity Cardiology CA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2022·2022-04-27

    Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display

    The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.

    Product
    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2022·2021-10-13

    Centricity Universal Viewer fails to save study changes to archive systems

    GE Healthcare's Centricity Universal Viewer has a software defect where changes to radiological studies are not saved to archive systems, potentially affecting clinician access to current image data.

    Product
    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2056-2021·2021-07-21

    GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images

    GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.

    Product
    Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states