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Medium risk Drugs & MedicationsClass II

Masimo Corporation Recall

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

Updated February 20, 2026

Masimo Corporation is recalling 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.

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

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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
Drugs & Medications
Recall ID
fda-Z-2670-2026
Classification
Class II
Recalled
February 20, 2026
Read the official notice

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