The Recall Desk

Hazard

Misdiagnosis recalls

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

What the numbers show

Total
94
Critical
0
Severe
7
Most recent
2026-08-12

Of the 94 misdiagnosis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (7%) 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 misdiagnosis 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.

26–50 of 94

  • HighFDA (Devices)·Z-0306-2021·2020-11-04

    GE Healthcare Recalls CT Scanners Due to Potential Image Artifacts

    GE Healthcare is recalling 64 CT scanners worldwide because incorrect settings may cause smudge artifacts that could be mistaken for pathology.

    Product
    Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2920-2020·2020-09-09

    Remel Bordetella pertussis Agglutinating Serum Recalled for False Negative Results

    Remel Europe Ltd. is recalling Thermo Scientific Remel Bordetella pertussis Agglutinating Serum because it may produce false negative results for serotypes 1 and 3.

    Product
    Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2873-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides because the drug etrombopag can interfere with test results, potentially leading to inaccurate total bilirubin measurements.

    Product
    VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2020·2020-07-08

    Fujifilm Synapse PACS Software Recalled for Incorrect Orientation Markers

    Fujifilm is recalling Synapse PACS Software versions 5.5.x and 5.7.x because incorrect orientation markers and slice locations may lead to misdiagnosis.

    Product
    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2020·2020-06-17

    Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2020·2020-05-27

    Cardinal Health Recalls B-Hydroxybutyrate LiquiColor Due to Temperature Abuse

    Cardinal Health is recalling B-Hydroxybutyrate LiquiColor test kits because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2020·2020-05-27

    Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse

    Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.

    Product
    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2020·2020-05-20

    CuattroDR System Software Recalled for Potential Image Misattribution

    Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

    Product
    CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1337-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images

    Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2020·2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2020·2020-02-26

    Siemens Ysio Max Radiographic System Recalled for Software Bug

    Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on ped
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2020·2020-01-29

    GE Healthcare Recalls Centricity Universal Viewer 6.0 for Measurement Errors

    GE Healthcare is recalling Centricity Universal Viewer 6.0 because incorrect measurements in DICOM files may lead to potential misdiagnosis.

    Product
    Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2020·2019-10-30

    Luminex xTAG Respiratory Viral Panel Recalled for False Negative Results

    Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.

    Product
    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2298-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1313-2019·2019-05-22

    BD Veritor Plus Analyzer Recalled for Potential Test Result Errors

    Becton Dickinson & Co. is recalling 32 BD Veritor Plus Analyzers because background calibration issues may cause false positive or negative test results.

    Product
    BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2019·2019-05-22

    BD Veritor System Reader Recalled for Potential False Test Results

    Becton Dickinson is recalling 124 BD Veritor System Readers due to background calibration issues that may cause false positive or negative test results.

    Product
    BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2019·2018-11-07

    BD Max Instrument Recall for False Positive Candida Results

    Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.

    Product
    BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2018·2018-08-22

    Beekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling O-SPOT REF 791 and 791S skin markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2831-2018·2018-08-22

    Beekley S-SPOT REF 777 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling S-SPOT REF 777 and 777S markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2018·2018-08-22

    Beekley TomoSPOT Mammography Skin Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling TomoSPOT skin markers used in mammography because they may create imaging artifacts that mimic calcifications on patient mammograms.

    Product
    TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2018·2018-05-16

    Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2018·2018-05-16

    Siemens Syngo.plaza Software Recalled to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza
    Category
    Medical Device
    Distribution
    Distributed nationwide