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Radius VSM recallZ-2670-2026 · Masimo Corporation · initiated Feb 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Masimo Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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/

Recall details

Recall number
Z-2670-2026
Status
Open, Classified
Initiated by the company
Feb 20, 2026
Posted by the FDA
Jul 2, 2026
Recalling firm
Masimo Corporation
Quantity
772
Product code
MHX
FDA submissions
K223498
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K223498 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98481).

Sources and updates

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