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.

126–150 of 178

  • SevereFDA (Devices)·Z-1648-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1649-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 145 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, posing a risk to patients in hospital settings.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1336-2016·2016-04-20

    Dexcom G4 PLATINUM Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM receivers because they may fail to provide intended audible alarms or alerts for diabetes patients.

    Product
    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT2064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2016·2016-04-20

    Dexcom G5 Mobile Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 41,925 G5 Mobile Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2016·2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers with Share because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2016·2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2016·2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 19,586 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in per
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2016·2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2016·2016-03-23

    CHG Hospital Beds Recalls Spirit Select Beds Due to Alarm Defect

    CHG Hospital Beds is recalling 1,892 Spirit Select beds because the bed exit alarm may fail to function, potentially delaying assistance after a patient fall.

    Product
    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2016·2016-03-02

    Philips IntelliVue Module Measurement X2 Recall for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG monitoring.

    Product
    Philips IntelliVue Module Measurement X2 Model: M3002A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2016·2016-03-02

    Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.

    Product
    Philips IntelliVue Measurement Module X1 Model: M3001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0374-2016·2015-12-16

    Philips IntelliVue Information Center iX Software Recall for Alarm Failure

    Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.

    Product
    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, param
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2779-2015·2015-09-23

    Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect

    Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.

    Product
    The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-1731-2015·2015-06-24

    HeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures

    HeartWare Inc. is recalling HVAD systems due to internal controller alarm battery failures. The recall affects 3,747 currently implanted devices worldwide.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1681-2015·2015-06-03

    Medtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure

    Medtronic is recalling specific SynchroMed II implantable drug pumps because the audible alarm may stop working, potentially preventing patients from detecting issues.

    Product
    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2015·2015-06-03

    Mindray Recalls Panorama Patient Monitoring Network Due to Software Anomaly

    Mindray is recalling four Panorama Patient Monitoring Network units due to a software anomaly that prevents arrhythmia alarms from displaying on the Panorama system after a restart.

    Product
    Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients withi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2015·2015-05-06

    Nihon Kohden Remote Network Station Recall for Alarm Failure

    Nihon Kohden America is recalling 208 Remote Network Station units because they may fail to sound alarms for critical patient conditions.

    Product
    Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device w
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1120-2015·2015-03-11

    Philips Allura Xper X-Ray Angiographic Software Recall

    Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.

    Product
    Philips Medical System Allura Xper X-Ray Angiographic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure

    Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1071-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Failing Alarm Assemblies

    Hospira Inc. is recalling 315 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at all volume levels.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1074-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Silent Alarm Defect

    Hospira is recalling nine Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1072-2015·2015-03-04

    Hospira Plum A+ Infusion Pump Alarm Assembly Recall

    Hospira is recalling 3,939 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1073-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps with Silent Alarm Defect

    Hospira is recalling 4,656 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1022-2015·2015-02-04

    Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure

    Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.

    Product
    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide