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.

101–125 of 163

  • HighFDA (Devices)·Z-0331-2022·2021-12-08

    Siemens Dimension Vista 500 software issue affects test accuracy

    Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

    Product
    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2022·2021-12-08

    Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults

    Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.

    Product
    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2022·2021-11-10

    Arietta 65 Ultrasound Software: Calculation Error in EROA Diagnostic Measurements

    Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.

    Product
    Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2022·2021-11-10

    Lisendo 880 Ultrasound Software displays incorrect cardiac valve measurements

    Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.

    Product
    Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2022·2021-11-10

    Arietta 750 Ultrasound Software Versions Affected by Incorrect Measurement Display

    FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.

    Product
    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2022·2021-10-20

    Blood sampling system sets recalled for pressure reading and measurement errors

    Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.

    Product
    smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0095-2022·2021-10-20

    Blood Sampling System Recalled for Pressure Shifts and Incorrect Readings

    Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0097-2022·2021-10-20

    Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors

    Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0098-2022·2021-10-20

    Medical Device Recall: Blood Sampling System Pressure and Reading Errors

    Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect blood collection accuracy.

    Product
    smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0094-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure measurement errors

    Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.

    Product
    smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0076-2022·2021-10-13

    Cardiosave IABP helium indicator may show inaccurate readings during electromagnetic interference

    Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0075-2022·2021-10-13

    Cardiosave Hybrid IABP Display Helium Indicator May Misread in Electromagnetic Interference

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2021·2021-08-18

    Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results

    Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.

    Product
    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2021·2021-07-28

    Medical Device Calibration Standard Assigned Incorrectly in NEFA CAL Kit

    Randox Laboratories recalls NEFA CAL IVD calibration standard kits (Batch 544642) due to incorrectly assigned calibration values that could cause measurement errors up to 8% in quality control and patient test results.

    Product
    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2021·2021-06-30

    Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors

    Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2021·2021-06-23

    Atellica CH 930 Analyzer photometer lamp may produce inaccurate results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with photometer lamps that may reach saturation without alerting users, potentially producing inaccurate patient test results.

    Product
    Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2020·2020-06-03

    Radiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors

    Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.

    Product
    ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2020·2020-06-03

    Radiometer ABL90 FLEX Analyzers Recalled for Hemolyzer Measurement Errors

    Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.

    Product
    ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide