Z-2671-2026Class II

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Name: Z-2671-2026 Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Creator: Masimo Corporation
Published: 2026-02-20
License: https://open.fda.gov/license/

Masimo Corporation / initiated 2026-02-20 / Open, Classified / root cause: manufacturing process

FDA source

Masimo Corporation began a recall of Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 on 2026-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2671-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-20
Posted: 2026-07-02
Recalling firm: Masimo Corporation
Product: Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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/
Quantity in commerce: 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, 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 codes and lots: REF/UDI-DI/Lot: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD; 4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2671-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2670-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2671-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code MHX

K223498Class IIRadius VSM and AccessoriesMasimo Corporation / cleared 2023-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)