The Recall Desk

Hazard

Measurement Error recalls

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

What the numbers show

Total
163
Critical
0
Severe
10
Most recent
2026-05-06

Of the 163 measurement error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (6%) 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 measurement 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.

76–100 of 163

  • HighFDA (Devices)·Z-2476-2023·2023-09-06

    Siemens epoc BGEM BUN Test Card Glucose Measurement Inaccuracy Recall

    Siemens Healthcare Diagnostics recalls 3,201 epoc BGEM BUN Test Cards due to potential for inaccurately high glucose readings in low-glucose samples.

    Product
    epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2477-2023·2023-09-06

    FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results

    Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.

    Product
    epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-2027-2023·2023-07-12

    FDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction

    GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.

    Product
    TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2029-2023·2023-07-12

    TruSignal Wrap Sensor Oximeter Recalled for Defibrillation Failure

    GE Healthcare is recalling 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.

    Product
    TruSignal Wrap Sensor, REF TS-W-D; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2028-2023·2023-07-12

    FDA Recalls GE Healthcare Oximeter Sensors for Defibrillation and Electrical Hazards

    GE Healthcare is recalling 2,097 TruSignal Sensitive Skin Sensor oximeters worldwide due to risks of reduced defibrillation energy, unintended electrical contact, and inaccurate measurements.

    Product
    TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2033-2023·2023-07-12

    GE TruSignal Ear Sensor Oximeter Recalled for Defibrillation Energy and Voltage Hazards

    GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce inaccurate measurements.

    Product
    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2030-2023·2023-07-12

    GE TruSignal Ear Sensor oximeter recalled for electrical and measurement hazards

    GE Healthcare is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.

    Product
    TruSignal Ear Sensor, REF TS-E-D; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1986-2023·2023-06-28

    Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications

    Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-1694-2023·2023-06-14

    ESR Diagnostic Quality Control Material Incorrectly Labeled as Different Level

    RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.

    Product
    RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2023·2023-06-07

    EarlyVue VS30 Vital Signs Monitor Missing Calibration Alarm

    Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.

    Product
    EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1480-2023·2023-05-31

    Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements

    Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.

    Product
    Luminos dRF Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2023·2023-05-03

    Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings

    Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.

    Product
    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2023·2023-03-22

    Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

    Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

    Product
    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2023·2023-03-01

    Diagnostic folate test kits recalled for negative measurement bias

    Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.

    Product
    ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2023·2022-10-26

    Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer

    The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2022·2022-07-06

    TEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager

    Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.

    Product
    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2022·2022-06-15

    Medical imaging software measurement accuracy error in Centricity PACS RA1000

    GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

    Product
    Centricity PACS RA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2022·2022-04-13

    SyncVision Systems cardiac imaging measurement error in same-session workflow

    SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.

    Product
    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0834-2022·2022-04-06

    FORE-SIGHT ELITE Tissue Oximeter: Inaccurate Oxygen Saturation Readings

    Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.

    Product
    FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2022·2022-03-09

    AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples

    Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.

    Product
    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0547-2022·2022-02-09

    Ultrasound System Software Calculation Error in Siemens ACUSON Sequoia

    Software error in certain Siemens ACUSON Sequoia ultrasound systems causes measurement values to be overestimated, potentially resulting in patient misdiagnosis.

    Product
    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2022·2022-02-02

    Siemens Diagnostic Angiography System Recalled for Multiple Software Defects

    Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.

    Product
    Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2022·2022-01-26

    ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall

    Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.

    Product
    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2022·2022-01-19

    Radiotherapy Planning Software BeamAdjust and VeriSoft Recalled for Measurement Errors

    PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.

    Product
    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
    Category
    Medical Device
    Distribution
    Distributed nationwide