The Recall Desk

Hazard

Alarm Failure recalls

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

What the numbers show

Total
178
Critical
5
Severe
23
Most recent
2026-09-02

Of the 178 alarm failure recalls we have scored against our rubric, 5 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (13%) 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 alarm 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.

101–125 of 178

  • ModerateFDA (Devices)·Z-0031-2019·2018-10-10

    Oridion Capnostream20 Bedside Monitors Recalled for Settings Reset Defect

    Oridion Medical is recalling 400 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 500 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER, Part Number CS08659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 22 refurbished Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling eight refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER, CS08660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2018·2018-04-25

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling Infinity Acute Care System monitoring solutions because invasive pressure alarms may not activate.

    Product
    Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2018·2018-02-21

    C.R. Bard Recalls CritiCore Monitors Due to Measurement and Alarm Failures

    C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.

    Product
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0202-2018·2017-12-13

    GE CARESCAPE Patient Data Module Recalled for Missing Apnea Alarms

    GE Medical Systems is recalling CARESCAPE Patient Data Module software because it fails to generate visual or audible alarms for impedance respiration apnea events.

    Product
    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/be
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2734-2017·2017-07-26

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling Infinity Acute Care Systems (M540) because specific units may fail to display audio or visual alarms.

    Product
    Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2250-2017·2017-06-14

    Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect

    Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.

    Product
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2017·2017-05-10

    Merge Healthcare Recalls Schiller CO2 Sensors Due to Alarm Bias

    Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.

    Product
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1773-2017·2017-04-19

    Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure

    Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.

    Product
    Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2017·2017-04-19

    Draegar Medical Systems Recalls Kappa and Scio Patient Monitors

    Draegar Medical Systems is recalling Kappa and Scio patient monitors because a low oxygen alarm may fail to sound when oxygen levels drop below the set limit.

    Product
    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2017·2017-04-19

    Draeger Medical Systems Recalls Delta Patient Monitors Due to Low Oxygen Alarm Failure

    Draeger Medical Systems is recalling Delta patient monitors used with Scio gas modules because the low oxygen alarm may fail to sound when oxygen levels drop below the set limit.

    Product
    Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2017·2017-04-12

    Philips IntelliVue MX4O Monitor Recall for Alarm Failure

    Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.

    Product
    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2017·2017-03-29

    CareFusion Alaris System PC Unit Recall for Battery Alarm Failure

    CareFusion is recalling Alaris System PC units because low battery alarms may fail to trigger before the battery discharges, stopping all infusion channels.

    Product
    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2017·2017-03-01

    Philips Efficia CMS200 Central Monitoring System Recalled for Pediatric Alarm Defect

    Philips is recalling 156 Efficia CMS200 central monitoring systems because they may not alarm appropriately for pediatric or neonatal patients.

    Product
    Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·17031·2016-11-10

    Kidde Recalls Combination Smoke and Carbon Monoxide Alarms Due to Failure

    Kidde is recalling about 3.6 million NightHawk combination smoke/CO alarms because they may fail to chirp at end-of-life, posing a risk of undetected fires or CO incidents.

    Product
    Kidde NightHawk combination smoke/carbon monoxide (CO) alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling IntelliVue MX40 patient monitors because a configuration setting may disable ECG alarms. The issue affects 9,804 units distributed in the US and 35 other countries.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling 1,824 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 4535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recalled for ECG Alarm Configuration Issue

    Philips is recalling 2,212 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms. Users should contact Philips for a software update.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 4535646153
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2886-2016·2016-10-05

    Spacelabs Xhibit Telemetry Receiver Recall for System Lockups

    Spacelabs Healthcare is recalling Xhibit Telemetry Receivers because the system may go offline or lock up, potentially failing to display alarms.

    Product
    Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2885-2016·2016-10-05

    Spacelabs Xhibit Central Station Recalled for System Lockups and Alarm Failures

    Spacelabs Healthcare is recalling Xhibit Central Stations because the telemetry system may go offline, lock up, or fail to display audio and visual alarms for asystole.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16269·2016-09-27

    SmartPool Recalls PE12 PoolEye Alarms Due to Switch Failure

    SmartPool is recalling PE12 PoolEye pool alarms because a reversed switch may prevent the alarm from sounding if a child enters the water. No injuries have been reported.

    Product
    PE12 PoolEye pool alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16760·2016-07-26

    Inovonics Recalls Emergency Transmitters and Receivers Due to Signal Failure

    Inovonics is recalling about 5,500 emergency transmitters and receivers because they may fail to send or receive help signals. No injuries have been reported.

    Product
    Inovonics pendant transmitters, universal transmitters and add-on receivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide