The Recall Desk

Hazard

Calibration Drift recalls

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

What the numbers show

Total
14
Critical
0
Severe
1
Most recent
2024-01-03

Of the 14 calibration drift recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (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 calibration drift 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.

1–14 of 14

  • HighFDA (Devices)·Z-0616-2024·2024-01-03

    Landauer microSTARii reader recalled for measurement inaccuracy

    Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.

    Product
    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0079-2024·2023-10-18

    Medfusion Syringe Pump Recalled for Occlusion Detection Calibration Drift

    Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.

    Product
    Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2024·2023-10-18

    Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall

    Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.

    Product
    Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2021·2021-09-15

    Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency

    Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.

    Product
    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0992-2020·2020-02-12

    Cardinal Health Genius 2 Tympanic Thermometer Recall for Accuracy Drift

    Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.

    Product
    Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2017·2017-01-25

    Binding Site Freelite Human Lambda Free SPAPlus Kit Recalled for Calibration Drift

    The Binding Site Group is recalling 1,002 units of the Freelite Human Lambda Free SPAPlus Kit because calibration curve activity increased over time.

    Product
    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0024-2015·2014-10-15

    Siemens Recalls Dimension Vista Mass CKMB Isoenzyme Calibrator Due to Drift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Mass CKMB Isoenzyme Calibrators because routine stability monitoring showed drift exceeding acceptance criteria.

    Product
    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0205-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 71 Plum A+ Infusion Pumps because pressure sensor calibration drift can cause false alarms or missed occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling 182,970 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or missed occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2014·2013-11-20

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Calibration Drift

    Hospira is recalling 179 Plum A+ Hyperbaric Infusion Pumps because distal pressure sensor calibration drift may cause false alarms or occlusions.

    Product
    Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false occlusion alarms or missed occlusions.

    Product
    *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 7,691 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or undetected occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide