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.

26–50 of 178

  • HighFDA (Devices)·Z-0866-2026·2025-12-10

    IntelliVue MX600 patient monitors recalled because an alarm may not sound

    Philips North America is recalling the IntelliVue Patient Monitor MX600 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue Patient Monitor MX600. Product Number: 865242.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2026·2025-10-08

    Washer disinfectors recalled over overheating risk from incorrect pressure calibration

    Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.

    Product
    Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2025·2025-06-25

    Portable Oxygen Concentrator with Erroneous Calibration Values

    Ohio Medical Corporation is recalling 36 units of the GCE HEALTHCARE Zen-O lite portable oxygen concentrator due to erroneous calibration values that may cause the device's alarm for low oxygen purity to function incorrectly as the device ages.

    Product
    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2025·2025-06-18

    Covidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall

    Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.

    Product
    Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2025·2025-02-26

    3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.

    Product
    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
    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-1107-2025·2025-02-12

    Patient Monitor May Fail to Alarm on Ventilator Disconnect

    Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.

    Product
    IntelliVue Patient Monitor MX400. Model Number: 866060
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1108-2025·2025-02-12

    Patient Monitor May Fail to Alert When Ventilator Disconnects

    Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.

    Product
    IntelliVue Patient Monitor MX450. Model Number: 866062
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1066-2025·2025-02-05

    Infinity Central Station speakers may fail to produce critical patient alarms

    Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.

    Product
    Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0884-2025·2025-01-22

    Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability

    The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.

    Product
    Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2024·2024-08-07

    Arctic Sun Temperature Management System software failure may disable critical safety alarms

    Arctic Sun Temperature Management Systems may fail to reach target temperature and critically fail to alert clinicians. The software defect affects approximately 10,507 units worldwide and risks hypothermia or hyperthermia.

    Product
    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2024·2024-07-31

    Wireless Nurse Call Station Recalled for Potential Alarm Communication Failure

    Arial Call Station wireless nurse call systems (models CSK200-1069 and CSK200-1069MR) are recalled due to risk of alarm communication failure and premature battery depletion. 77 units affected across multiple U.S. states.

    Product
    Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2437-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk

    B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2024·2023-12-20

    Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures

    Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.

    Product
    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2024·2023-11-15

    Arial Water Resistant Pendant Alarm Recalled for Battery Depletion Risk

    Securitas Healthcare is recalling Arial Water Resistant Pendants (models 59360 and 2560-59360) due to premature battery depletion that may prevent emergency alarms from being received.

    Product
    Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2024·2023-11-15

    Pendant Patient Alarm Battery Defect Prevents Emergency Alerts

    Securitas Healthcare LLC recalls Arial Water Resistant Pendants (Models 59361 and 2560-59361) because premature battery depletion may prevent emergency alarms from reaching the wireless alert system. Affected patients may not receive emergency assistance when needed.

    Product
    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2024·2023-11-01

    ResMed Astral ventilators recalled for power loss and failed alarms

    ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.

    Product
    Astral 100 and Astral 150 ventilators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2023·2023-10-11

    EarlyVue VS30 Vitals Monitor May Fail to Alarm on Respiration Rate Violations

    A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.

    Product
    EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2023·2023-10-11

    Philips EarlyVue VS30 Monitor Software Flaw Disables Respiration Alarms

    Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.

    Product
    EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2430-2023·2023-08-30

    Infusion pump alarm may fail to sound due to manufacturing defect

    ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.

    Product
    Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 30010341
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1503-2023·2023-05-10

    FDA Class II Recall: Ultraview SL Command Module Monitoring Alarms May Fail

    Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.

    Product
    Ultraview SL (UVSL) Command Module, Model 91496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2022·2022-07-20

    Vivo 45LS Ventilator processor failure alarm not generated on shutdown

    Breas Medical recalls 1,113 Vivo 45LS Ventilators due to a processor that can fail without triggering an alarm, potentially preventing detection of ventilator malfunction if monitoring instructions are not followed.

    Product
    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1271-2022·2022-06-29

    Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures

    Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.

    Product
    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
    Category
    Medical Device
    Distribution
    Distributed nationwide