Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
FDA Recall Z-2671-2026 · Posted 2026-07-02
Recalling FirmMasimo Corporation
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2026-02-20
Product Quantity1,028
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.
Firm Action
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 [email protected]
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 [email protected] In addition, Technical Service: https://www.masimo.com/contact-support/support/technical-services/
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.