FDA Medical Device Recalls (openFDA)
Masimo Corporation: Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
- Recall number
- Z-2671-2026
- Recalling firm
- Masimo Corporation
- Product
- Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
- Status
- Open, Classified
- Initiated
- 2026-02-20
- Posted
- 2026-07-02
- Terminated
- not on file
- Reason
- 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
- 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 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/
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K223498"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3011353843
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28