Masimo Radius VSM Disposable NIBP Cuff recalled for false heart rate alarms and skin irritation risk
What this means
Masimo Corporation is recalling certain Radius VSM Disposable NIBP Cuff devices due to two issues: the ECG electrode may incorrectly detect abnormal heart rhythms in patients with normal heart rates, triggering false alarms that can distract clinicians; and small and medium-sized blood pressure cuffs may have rough edges that can irritate skin. These issues could delay proper treatment or patient discomfort in healthcare settings.
- Check if your device matches the recalled lot numbers (4825 or 4826 with specific lot codes listed).
- Stop using the affected cuff and contact Masimo or your supplier for a replacement or corrective action.
- Report any injuries or false alarms to the FDA MedWatch program.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2671-2026More Masimo Corporation recalls
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