Masimo Radius VSM NIBP Cuff and ECG Set
Masimo recalls Radius VSM NIBP cuffs and ECG sets over false heart-rate alarms and cuff edge irritation.
Stop using the affected Radius VSM Disposable NIBP Cuffs (REF 4825, 4826) and ECG pre-connected Sets (REF 4842, 4695) and contact Masimo for replacement instructions.
Why it was recalled
Masimo is recalling the Radius VSM Disposable NIBP Cuff (REF 4825, 4826) and the Radius VSM ECG pre-connected Set (REF 4842, 4695). The ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger alarms on patients with normal heart rates, which could distract clinicians from true alarms and delay treatment. Small and medium blood pressure cuffs may also 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 | Recall # | UDI-DI |
|---|---|---|
| Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Z-2670-2026 | 10843997011003, 10843997016015 |
| Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | Z-2671-2026 | 00843997006989, 10843997006993 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-18 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification