The Recall Desk

Hazard

Data Integrity recalls

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

What the numbers show

Total
276
Critical
0
Severe
9
Most recent
2026-08-19

Of the 276 data integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (3%) 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 data integrity 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.

76–100 of 276

  • HighFDA (Devices)·Z-1051-2019·2019-04-03

    BD Synapsys Laboratory Software Recalled for Incorrect Test Order Association

    Becton Dickinson is recalling BD Synapsys version 2.1 because it allowed test orders to be associated with incorrect culture records.

    Product
    BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0795-2019·2019-02-13

    Medtronic CareLink 2090 Programmer Recalled for Longevity Display Error

    Medtronic is recalling CareLink 2090 programmers because they may incorrectly display the remaining longevity value for up to two years before the device reaches its Recommended Replacement Time.

    Product
    MEDTRONIC CARELINK 2090 programmer
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0513-2019·2018-12-05

    PerkinElmer QSight 210 MD Mass Spectrometer Software Data Overwrite Recall

    PerkinElmer is recalling 18 QSight 210 MD mass spectrometers because a software defect may overwrite original data from the last acquired sample when automatic flush is enabled.

    Product
    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0471-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect

    Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.

    Product
    1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect

    Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.

    Product
    COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0374-2019·2018-11-14

    GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure

    GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0195-2019·2018-10-24

    GE Healthcare Recalls Centricity Universal Viewer Due to Patient Data Error

    GE Healthcare is recalling Centricity Universal Viewer software because remote comparison studies may display incorrect patient data without a warning icon.

    Product
    Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2992-2018·2018-09-12

    Hitachi VidiStar PACS Software Recalled for Potential Image Mix-Up

    Hitachi is recalling VidiStar PACS software versions 3.10.5 and 3.10.6 because a defect may cause images from multiple patients to appear in a single study.

    Product
    VidiStar(TM) PACS & DICOM Viewer Software system
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2184-2018·2018-06-20

    CellaVision DM Software Recall for LIS Data Transmission Malfunction

    Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 due to a malfunction where cell comments are not sent to the Laboratory Information System.

    Product
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2018·2018-06-13

    NordicNeuroLab Recalls nordicICE Software Due to Coregistration Visualization Error

    NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.

    Product
    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2018·2018-05-30

    Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue

    Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.

    Product
    Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1778-2018·2018-05-16

    Siemens Syngo.Via Software Recall for Report Functionality Defect

    Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.

    Product
    Syngo.Via VB20A model 1049610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2018·2018-04-25

    GE Healthcare Lunar DPX Duo and Bravo Bone Density Software Recall

    GE Healthcare is recalling Lunar DPX Duo and Bravo bone density scanners because a software issue may cause reports to be filed under the wrong patient name in the hospital system.

    Product
    GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2018·2018-04-25

    GE Healthcare Prodigy Ultrasound Recall for Incorrect Patient Data in Reports

    GE Healthcare is recalling Prodigy and Prodigy Advanced ultrasound systems because bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.

    Product
    GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2018·2018-04-25

    GE Healthcare Lunar DPX Bone Density Systems Recalled for Data Errors

    GE Healthcare is recalling 43 Lunar DPX bone density systems because patient reports may be sent to hospital systems with incorrect names in the header.

    Product
    GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1303-2018·2018-04-11

    Siemens Syngo.via Software Recall for Incorrect Report Data

    Siemens is recalling Syngo.via software because it fails to save corrected report values, potentially sending outdated information to physicians.

    Product
    Syngo.via. Medical Device Software. Picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1302-2018·2018-04-11

    GE Healthcare Recalls Centricity PACS-IW Due to Image Data Loss Risk

    GE Healthcare is recalling 569 units of Centricity PACS-IW because a database error may cause image series to be missing from exams without user notification.

    Product
    GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0926-2018·2018-03-14

    Abbott i-STAT DE Handheld Module Software Update Recall

    Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.

    Product
    i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0662-2018·2018-02-28

    Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error

    Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.

    Product
    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0659-2018·2018-02-28

    Fujifilm Aspire HD Mammography System Recalled for Image ID Error

    Fujifilm is recalling Aspire HD mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0660-2018·2018-02-28

    Fujifilm Recalls Digital Mammography Systems Due to Image ID Error

    Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening
    Category
    Medical Device
    Distribution
    0 states