Masimo Radius VSM ECG Set and NIBP Cuff
Masimo recalls Radius VSM ECG Sets and NIBP Cuffs over false alarms and skin irritation risks.
Stop using the affected devices and contact Masimo Corporation for instructions on returning the products and obtaining replacements.
Why it was recalled
Masimo Corporation is recalling the Radius VSM ECG pre-connected Set (REF 4842, 4695) because the ECG feature may incorrectly detect extreme bradycardia or tachycardia and trigger alarms on normal heart rate patients, potentially delaying treatment. Also recalled are the Radius VSM Disposable NIBP Cuffs (REF 4825, 4826) which may have rough edges that can cause skin irritation or redness.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Radius VSM ECG pre-connected Set, REF: 4842, 4695 | 10843997011003, 10843997016015 | Z-2670-2026 |
| Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | 00843997006989, 10843997006993 | Z-2671-2026 |
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification