Masimo Corporation recalls Radius VSM ECG pre-connected Set

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.

On 2/20/2026 / 3/4/3036 recall notices/updated notices were mailed to customers who were asked to do the following: 1) Always pay attention to alerts and alarms displayed and post this notice as a constant reminder for those using the devices. 2) Post this notification as a constant reminder for anyone using the devices. 3) If you wish to return the impacted devices, please contact the firm's Technical Services; see email below. 4) Complete the bottom portion of the notice and return via email to CustomerNotice@masimo.com Customer Care is available at 1-800-916-1270 for US customers Monday through Friday from 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. For international customers local contact information can be found at https://www.mymasimo.com/contact-us/ Masimo Customer Care can also be contacted via email at customercare@masimo.com In addition, Technical Service: https://www.masimo.com/contact-support/support/technical-services/

• FDA enforcement recordOfficial FDA database entry for Z-2670-2026
• FDA 510(k) clearance · K223498The device's official FDA premarket clearance record
• FDA device classification · MHXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1025The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Masimo CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.