Masimo Recalls
13 recalls on record · May 8, 2013 to July 8, 2026 · Medical Devices
Recalls by year
13
14
15
23
24
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026Medical DevicesFDA
Masimo Corporation recalls Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Hazard: 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.
July 8, 2026Medical DevicesFDA
Masimo Corporation recalls Radius VSM ECG pre-connected Set, REF: 4842, 4695
Hazard: 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.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
June 28, 2023Medical DevicesFDA
Masimo Corporation recalls Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Hazard: TC-I tip clip sensor may produce readings outside the accuracy specification.
June 28, 2023Medical DevicesFDA
Masimo Corporation recalls Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Hazard: TC-I tip clip sensor may produce readings outside the accuracy specification.
June 28, 2023Medical DevicesFDA
Masimo Corporation recalls Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Hazard: TC-I tip clip sensor may produce readings outside the accuracy specification.
June 28, 2023Medical DevicesFDA
Masimo Corporation recalls Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Hazard: TC-I tip clip sensor may produce readings outside the accuracy specification.
December 2, 2015Medical DevicesFDA
Masimo Corporation recalls rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No.
Hazard: These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
November 19, 2014Medical DevicesFDA
Masimo Corporation recalls Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasi
Hazard: Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
May 8, 2013Medical DevicesFDA
Masimo Corporation recalls Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvas
Hazard: Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.