Masimo Corporation 2026-07-08 Health serious FDA
Health · FDA · Recall #FDA-Z-2670-2026
Radius VSM ECG pre-connected Set, REF: 4842, 4695 Recall
Issued July 8, 2026 · Masimo Corporation
In July 2026, Masimo Corporation recalled the Radius VSM ECG pre-connected Set, REF: 4842, 4695, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Radius VSM ECG pre-connected Set, REF: 4842, 4695 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Masimo Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Masimo Corporation
- Category
- Health
- Recall date
- July 8, 2026
- Units affected
- Not reported
- Sold at
- 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 I
- Recall number
- FDA-Z-2670-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Masimo Corporation has 3 recalls in our database.
- We're tracking 3,673 Health recalls in our database.
- This is the 453rd Health recall we've logged in 2026.