Masimo Corporation: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary Masimo Corporation is recalling Radius VSM Disposable NIBP Cuff (models REF: 4825, 4826) due to two issues: the ECG electrode assembly may incorrectly detect abnormal heart rhythms and trigger false alarms in patients with normal heart rates, which could distract clinicians from legitimate alarms and delay treatment; and small and medium-sized blood pressure cuffs may have rough edges that could cause skin irritation or redness. The recalled devices have been distributed nationwide in the U.S. and internationally.
- Recalling firm
- Masimo Corporation
- Product
- Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ebcdf6f3-8daf-4742-b4dd-e204ee5da159