Masimo Corporation
10 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Masimo Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-08FDA-DeviceClass IIMasimo Radius VSM cuff recalled for false alarms and rough edges
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.
- 2026-07-08FDA-DeviceClass IIMasimo Radius VSM ECG set recalled for false alarms and cuff irritation
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.
- 2024-04-24FDA-DeviceClass IIMasimo 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.
- 2024-04-24FDA-DeviceClass IIMasimo 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.
- 2024-04-24FDA-DeviceClass IIMasimo 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.
- 2024-04-24FDA-DeviceClass IIMasimo 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.
- 2023-06-28FDA-DeviceClass IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceClass IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceClass IIMasimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceClass IIMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
TC-I tip clip sensor may produce readings outside the accuracy specification.
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