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.

76–100 of 178

  • HighFDA (Devices)·Z-0943-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling eight Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0954-2020·2020-02-26

    Philips Respironics Recalls LifeVent EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 29 LifeVent EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate access
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1125-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.

    Product
    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2020·2020-02-19

    Dexcom G6 CGM App iOS Software Recall for Low Alarm Defect

    Dexcom Inc is recalling the Dexcom G6 CGM App for iOS due to a software defect that may prevent low blood glucose alarms from triggering correctly.

    Product
    Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1123-2020·2020-02-19

    Flowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2020·2020-02-19

    Flowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.

    Product
    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2020·2020-02-19

    Flowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling Prometra II 40mL implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0915-2020·2020-02-12

    ResMed Stellar Ventilators Recalled for Potential Alarm Failure

    ResMed is recalling 69 Stellar ventilators because a software and component failure may prevent audible alarms from operating properly.

    Product
    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0610-2020·2019-12-18

    Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall

    Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.

    Product
    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0175-2020·2019-10-30

    GE Healthcare ApexPro Telemetry Server System Recall for Alarm Failure

    GE Healthcare is recalling ApexPro Telemetry Server Systems because they may fail to provide visual or audible alarms for ECG arrhythmias, lead failures, or pulse oximetry issues.

    Product
    ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2019·2018-10-10

    Oridion Capnostream20 N Monitors Recalled for Settings Reset Issue

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

    Product
    Capnostream20 N W/PRINTER CYVITAL, CS08798
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Monitors Recalled for Settings Reset

    Oridion Medical is recalling 264 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2019·2018-10-10

    Oridion CapnoStream 20P Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 1,038 CapnoStream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2019·2018-10-10

    Oridion CapnoStream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 192 CapnoStream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2019·2018-10-10

    Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 3,143 CAPNOSTREAM 20 patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (US) N, Part Number CS08651
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N, Part Number CS08651-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0053-2019·2018-10-10

    Oridion Capnostream20 Patient Monitors Recalled for Settings Reset

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

    Product
    Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2019·2018-10-10

    Oridion Capnostream20 M Bedside Patient Monitor Recall for Settings Reset

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

    Product
    Capnostream20 M W/PRINTER CYVITAL, CS08796
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall

    Oridion Medical is recalling 113 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 113 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2019·2018-10-10

    Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 696 Capnostream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
    Category
    Medical Device
    Distribution
    Distributed nationwide