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Medium risk Medical DevicesClass II

Masimo Radius VSM ECG Set Recall

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Updated February 20, 2026

Masimo's Radius VSM ECG pre-connected set may incorrectly detect abnormal heart rates in patients with normal rhythms, potentially triggering false alarms that distract clinicians from real alerts. Small and medium blood pressure cuffs in the set may also have rough edges that irritate skin.

Is the Masimo Corporation recalled? Yes. This product was recalled by FDA on February 20, 2026. Details below.

What is recalled

Masimo Radius VSM ECG pre-connected set, reference numbers 4842 and 4695. The set includes an ECG electrode assembly and small and medium sized blood pressure cuffs.

Am I affected

You're affected if you use or have access to the Masimo Radius VSM ECG pre-connected set with reference number 4842 or 4695 in a clinical or hospital setting.

What to do right now

Contact Masimo Corporation or your healthcare facility's equipment manager to report which units you have and receive instructions for replacement, repair, or return.

The 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.

Brands affected

Masimo Corporation
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2670-2026
Classification
Class II
Recalled
February 20, 2026
Read the official notice

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