Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

FDA device recall Z-2671-2026 · posted 2026-07-02 · Open, Classified

Recall details

Recalling firm

Masimo Corporation

Reason for recall

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.

Action taken

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/

Root cause

Process control

Status

Open, Classified

Product code

MHX

Quantity affected

1,028

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, Fr

Date initiated

2026-02-20

Date posted

2026-07-02

Location

Irvine, CA

Related 510(k) clearances