Hazard

Incorrect Reading recalls

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

What the numbers show

Total: 18
Critical: 0
Severe: 1
Most recent: 2021-03-17

Of the 18 incorrect reading 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 (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 incorrect reading 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.

1–18 of 18

HighFDA (Devices)·Z-1181-2021·2021-03-17
Getinge Flow i Anesthesia Systems Recalled for Absorber Docking Failures
Getinge Group Logistics America is recalling 144 Flow i Anesthesia Systems due to complaints of incorrect FiCO2 readings and System Check Out failures when docking the absorber.
Product
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0859-2021·2021-01-20
ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue
ICU Medical is recalling 220 Cogent Hemodynamic Monitoring Systems because a software issue may cause the display to show incorrect continuous cardiac output values after calibration.
Product
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2429-2020·2020-07-01
Suntech Oscar 2 Blood Pressure Monitor Recall for Display Error
Suntech Medical is recalling Oscar 2 blood pressure monitors because the display may show an incorrect decimal point for three-digit readings in mmHg.
Product
Oscar 2, Model 250 System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2785-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2758-2018·2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 475 Temperature Sensor Foley Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2018·2018-03-21
Draeger Infinity Dual Hemo MCable Pod Recall for Liquid Ingress Risk
Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.
Product
INFINITY DUAL HEMO MCable Pod
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2883-2016·2016-10-05
Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings
Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.
Product
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2722-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling a 6 mm Transonic Flow Probe due to a software defect causing incorrect meter readings.
Product
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2729-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 6 mm Flow Probes due to programming errors causing incorrect meter readings.
Product
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2720-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Product
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2726-2015·2015-09-09
Transonic Flow Probe Recall Due to Software Defect in EPROM
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Product
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2721-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 36 Transonic Flow Probes due to programming errors that cause incorrect meter readings.
Product
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2727-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.
Product
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2728-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects causing incorrect meter readings.
Product
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2724-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Product
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2014·2014-06-25
Spacelabs Ventilator Interface Recalled for Minute Volume Display Error
Spacelabs Healthcare is voluntarily recalling Ventilator Flexport Interfaces because the bedside monitor may display minute volume values up to ten times the actual value.
Product
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1175-2014·2014-03-19
GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
GE Healthcare is recalling CARESCAPE Monitor B650 and B850 units due to potential safety issues with Non-Invasive Blood Pressure and Bed to Bed functions.
Product
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0602-2014·2014-01-08
Integra Camino Advanced Monitor Recalled for Reversed Pressure Display
Integra LifeSciences is recalling 275 Camino Advanced Monitors because a firmware error may display reversed systolic and diastolic intracranial pressure values.
Product
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipp
Category
Medical Device
Distribution
Distributed nationwide