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.

1–25 of 35

  • HighFDA (Devices)·Z-2049-2026·2026-05-13

    LUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure

    Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.

    Product
    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2025·2025-02-12

    IntelliBridge EC10 Module may fail to alarm on ventilator disconnection

    The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.

    Product
    IntelliBridge EC10 Module. Model Number: 865115
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0203-2025·2024-10-30

    Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring

    Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.

    Product
    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0186-2025·2024-10-30

    TranStar Disposable Pressure Transducer Kit recalled for manufacturing defect

    Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability to zero the device.

    Product
    medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0201-2025·2024-10-30

    Blood Sample Pressure Kit Recalled for Monitoring Defects

    Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.

    Product
    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0196-2025·2024-10-30

    medex TranStar Neonatal Monitoring Kit Recalled Due to Pressure Transducer Defect

    Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.

    Product
    medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3124-2024·2024-09-18

    Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines

    Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.

    Product
    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2024·2024-06-12

    Bedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms

    Nihon Kohden's BSM-3000 Series Bedside Monitors may produce false SpO2 probe failure alarms due to a software issue. Healthcare facilities should contact the manufacturer for guidance.

    Product
    BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2023·2023-07-05

    NaviCare Patient Safety software versions recalled for alert suppression defect

    Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.

    Product
    NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2023·2023-05-03

    Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring

    The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.

    Product
    HAMILTON-C6, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2023·2023-05-03

    Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect

    Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.

    Product
    Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2023·2023-02-08

    Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall

    Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0795-2022·2022-05-04

    NAD+ Compounded Drug Recall for Manufacturing Quality Control Violations

    Olympia Compounding Pharmacy is recalling NAD+ lyophilized powder (16,329 vials nationwide) due to failure to properly investigate environmental and personnel monitoring violations in manufacturing.

    Product
    NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2022·2022-05-04

    PGE-1 Alprostadil Injection Recalled for Manufacturing Process Deviations

    Olympia Compounding Pharmacy is recalling 821 vials of PGE-1 Alprostadil 40 mcg/mL injection nationwide. The recall is due to Current Good Manufacturing Practice deviations in environmental and personnel monitoring procedures that were not properly investigated.

    Product
    PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2020·2021-02-03

    Philips Telemetry Transceiver Recall for Heart Rate Display Failure

    Philips is recalling TRx4841A telemetry transceivers because they may fail to display heart rates or alarms when used with specific Patient Information Center software.

    Product
    TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0980-2020·2020-02-12

    Pacific Medical Fetal Transducers Recalled for Lack of Regulatory Clearance

    Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.

    Product
    Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2155-2019·2019-08-14

    SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure

    SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1320-2019·2019-05-22

    Philips SureSigns VS3 Monitor Software Defect Recall

    Philips is recalling 3,177 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2018·2018-06-27

    Datex-Ohmeda CARESCAPE R860 Ventilators Recalled for Display Processor Failure

    Datex-Ohmeda is recalling CARESCAPE R860 ventilators with software version 10SP05 because the display processor may experience unexpected failure.

    Product
    CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocess
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2018·2018-01-31

    Medtronic MyCareLink Smart Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.

    Product
    MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0399-2018·2018-01-31

    Medtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring notifications.

    Product
    MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0348-2018·2018-01-24

    Philips Recalls ECG Out Cables Due to Electrical Interference Risk

    Philips is recalling specific ECG out and sync cables because electrical interference may cause monitors to misinterpret signals or disable monitoring.

    Product
    ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2727-2017·2017-07-19

    Natus Neurology Recalls Elite Obstetric Probes Due to Excessive Background Noise

    Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask fetal heart rate and blood flow monitoring.

    Product
    Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1768-2017·2017-04-19

    Nihon Kohden Bedside Monitor Recall for Pause Function Defect

    Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.

    Product
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2015·2015-05-13

    Spacelabs Ultraview SL Command Modules Recalled for Random Resets

    Spacelabs is recalling Ultraview SL Command Modules with specific Masimo SpO2 components due to a defect causing random resets.

    Product
    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate
    Category
    Medical Device
    Distribution
    Distributed nationwide