Masimo Corporation recalls Radius VSM ECG pre-connected Set

Recalling company

Masimo Corporation

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 20, 2026

Reported

Jul 8, 2026

Distribution

Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.

Status

Ongoing

Quantity

772

Lot / codes

REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF

Company location

Irvine, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2670-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2670-2026 in the FDA Enforcement Report. Also see FDA recall press releases.