The Recall Desk

Hazard

Inaccurate Data recalls

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

What the numbers show

Total
25
Critical
0
Severe
0
Most recent
2026-09-02

Of the 25 inaccurate data recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate data 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.

1–25 of 25

  • HighFDA (Devices)·Z-3012-2026·2026-09-02

    Midmark IQecg Digital ECG Software Recall for Inaccurate Waveforms

    Midmark is recalling IQecg Digital ECG software due to a communication anomaly that may cause incorrect waveforms and inaccurate heart rate calculations.

    Product
    Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2020·2020-05-06

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues

    ICU Medical is recalling 83 Cogent Hemodynamic Monitoring Systems due to software issues that may cause inaccurate data, unit shutdown, or loss of display.

    Product
    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1547-2020·2020-04-01

    Randox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values

    Randox Laboratories is recalling Chemistry QC Premium Plus due to incorrect Sodium target values. The error affects quality control accuracy for diagnostic assays.

    Product
    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2020·2019-11-13

    Insulet Recalls Omnipod DASH Insulin Systems Due to Communication Interruption

    Insulet Corporation is recalling 264 units of the Omnipod DASH Insulin Management System because a communication interruption may cause inaccurate insulin data to be displayed.

    Product
    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2020·2019-11-06

    Medtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates

    Medtronic is recalling 6,713 CareLink Encore Programmer units worldwide because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0239-2020·2019-11-06

    Medtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates

    Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0069-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recall for Potential False High Counts

    Becton, Dickinson and Company is recalling 78 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0614-2019·2018-12-26

    Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors

    Philips is recalling 651 Xper Flex Cardio Physiomonitoring Systems because software defects may cause inaccurate waveform displays, frozen oxygen saturation values, or non-updating blood pressure readings.

    Product
    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0108-2019·2018-10-24

    Carl Zeiss IOLMaster 700 Recalled for Incorrect Calibration Settings

    Carl Zeiss Meditec AG is recalling one IOLMaster 700 system because a manufacturing error caused incorrect calibration, leading to inaccurate eye images.

    Product
    Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2707-2017·2017-07-19

    Merge Healthcare Recalls Schiller PB 1000 Patient Data Module

    Merge Healthcare is recalling 555 Schiller PB 1000 Patient Data Modules because the analog output may not accurately reflect the pressure waveform used for fractional flow reserve calculations.

    Product
    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2017·2016-11-23

    Sorin Orchestra Plus Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is recalling 586 Orchestra Plus programmers because their residual longevity estimates may be inaccurate, potentially affecting patient monitoring.

    Product
    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2017·2016-11-23

    Sorin Orchestra Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is voluntarily recalling 847 Orchestra and Orchestra Plus programmers because residual longevity estimates may be inaccurate.

    Product
    The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2016·2016-08-24

    Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy

    Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.

    Product
    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging sys
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2017-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Upgrade Recalled for Calibration Error

    Siemens Medical Solutions is recalling 2 Biograph TruePoint scanner upgrades because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2016-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling Biograph 6-4R TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0831-2015·2014-12-24

    Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values

    Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2015·2014-11-05

    Merge Hemo Diagnostic Computer Recalled for Stale Oxygen and Heart Rate Data

    Merge Healthcare is recalling 52 Hemo Programmable diagnostic computers because the SpO2 and heart rate values displayed may not update to reflect changes in the patient's condition.

    Product
    Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2015·2014-10-15

    McKesson Cardiology Hemo Software Recall for Hemoglobin Calculation Error

    McKesson Information Solutions LLC is recalling 272 McKesson Cardiology Hemo devices because a software error incorrectly converts hemoglobin values used in formula calculations.

    Product
    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2014·2014-10-01

    Philips CT Scanner Recall Due to Inaccurate Extended Display Reconstruction

    Philips Medical Systems is recalling 61 CT scanners because the Extended Display Field of View reconstruction feature produces inaccurate CT numbers and anatomy.

    Product
    No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1511-2014·2014-05-07

    GE Healthcare Recalls CardiacVX Software Due to Inaccurate Flow Values

    GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.

    Product
    GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the revi
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0773-2014·2014-01-22

    GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors

    GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.

    Product
    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2013·2012-11-14

    Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error

    Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.

    Product
    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained
    Category
    Medical Device
    Distribution
    1 state