The Recall Desk

Hazard

Monitoring Failure recalls

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

What the numbers show

Total
35
Critical
0
Severe
1
Most recent
2026-05-13

Of the 35 monitoring failure 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 (3%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all monitoring failure 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.

26–35 of 35

  • HighFDA (Devices)·Z-0106-2015·2014-10-29

    Ad-Tech Cueva Electrode Kits Recalled for Potential Wand Malfunction

    Ad-Tech Medical Instrument Corporation is recalling Cueva Electrode Kits because the applicator wand may malfunction, potentially preventing monitoring of the VII cranial nerve.

    Product
    Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2014·2014-08-06

    Baxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss

    Baxter Healthcare is recalling 1,315 FlowCOUPLER implantable devices because some units may lose electrical continuity, preventing proper monitoring of blood flow.

    Product
    FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2085-2014·2014-07-30

    GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss

    GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.

    Product
    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2014·2014-05-14

    GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software may cause false oxygen saturation and pulse rate alarms.

    Product
    Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arteri
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0808-2014·2014-01-29

    GE Healthcare Recalls TRAM Modules Due to Intermittent ECG Noise

    GE Healthcare is recalling 1,948 TRAM Modules because movement of the ECG cable connector causes intermittent noise on ECG and respiration waveforms, potentially reducing monitoring performance.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2014·2014-01-29

    GE Healthcare Recalls Dash Patient Monitors Due to ECG Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because cable movement causes intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2014·2014-01-29

    GE Healthcare Patient Data Module Recall for ECG Noise

    GE Healthcare is recalling 2,516 Patient Data Modules due to intermittent noise on ECG and respiration waveforms that may reduce monitoring performance.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2014·2014-01-01

    Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error

    Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.

    Product
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2013·2013-02-06

    Mindray Recalls DPM5 Monitors Due to Missing ST and Arrhythmia Features

    Mindray is recalling 13 DPM5 vital signs monitors because ST and Arrhythmia features may not be available.

    Product
    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2013·2012-12-26

    GE Healthcare Recalls Dash Patient Monitors Due to NBP Cycling Issue

    GE Healthcare is recalling 119,260 Dash 3000/4000/5000 patient monitors due to a potential issue where Custom Automatic NBP Measurement cycling may stop unexpectedly.

    Product
    GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients
    Category
    Medical Device
    Distribution
    Distributed nationwide