Masimo Corporation Recalls

6 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (6)

February 20, 2026
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.
Class II
February 20, 2026
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.
Class II
February 15, 2024
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.
Class II
February 15, 2024
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.
Class II
February 15, 2024
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.
Class II
February 15, 2024
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.
Class II

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