Masimo Corporation
FDA adverse event reports naming Masimo Corporation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MASIMO CORPORATION.
- Total reports
- 2,938
- Deaths
- 73
- Injuries
- 161
- Malfunctions
- 2,644
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- OximeterDQA2,870
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI21
- Oximeter, Tissue SaturationMUD13
- System, Network And Communication, Physiological MonitorsMSX12
- Full-Montage Standard ElectroencephalographGWQ10
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX6
- Oximeter, EarDPZ2
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2
- Cable, Transducer And Electrode, Patient, (Including Connector)DSA2
- Continuous Measurement ThermometerFLL2
Recent recalls
- 2026-07-02Open, ClassifiedProcess control
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- 2026-07-02Open, ClassifiedProcess control
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- 2024-04-12Open, ClassifiedMaterial/Component Contamination
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-12Open, ClassifiedMaterial/Component Contamination
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-12Open, ClassifiedMaterial/Component Contamination
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-12Open, ClassifiedMaterial/Component Contamination
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2023-06-21Open, ClassifiedNonconforming Material/Component
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-21Open, ClassifiedNonconforming Material/Component
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-21Open, ClassifiedNonconforming Material/Component
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-21Open, ClassifiedNonconforming Material/Component
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
TC-I tip clip sensor may produce readings outside the accuracy specification.
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