Masimo recalls Radius VSM ECG pre-connected sets with potential false alarms for heart rate issues and skin irritation from rough edges on blood pressure cuffs.
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.
Masimo is recalling Radius VSM ECG pre-connected sets that may give false alarms for heart rate problems and cause skin irritation from rough edges on blood pressure cuffs. This could distract clinicians from real medical issues or cause discomfort.
The ECG electrode assembly might incorrectly flag heart rate issues in normal patients, causing false alarms that could delay real medical care. Blood pressure cuffs with rough edges might irritate skin, causing redness or discomfort.
Healthcare professionals using the Radius VSM ECG sets for patient monitoring are most at risk. Patients with heart conditions may be affected by false alarms.
Check for model numbers 4842 or 4695 on the product. The specific reference codes include 4842/10843997011003/25AJH, 25KMA, 25MSC and 4695/10843997016015/24N17, 25BBJ, 25DMH, etc.
Look for model numbers 4842 or 4695 on the device and check the reference codes listed in the recall notice.
The ECG electrode assembly may give false alarms for heart rate issues, which could distract clinicians from real medical problems. Blood pressure cuffs may have rough edges causing skin irritation.
Check for model numbers 4842 or 4695 with reference codes like 4842/10843997011003/25AJH or 4695/10843997016015/24N17.
The recall notice does not specify a remedy, so contact Masimo Corporation for further instructions.
We’ve drafted a message you can send Masimo to request your refund or repair — edit it as you like.
Subject: Recall Z-2670-2026 — Masimo Masimo Hello, I own a Masimo that is covered by recall Z-2670-2026 from Masimo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
