Masimo recalls Radius VSM Disposable NIBP Cuffs with REF 4825/4826 due to potential incorrect heart rate alarms and skin irritation from rough edges. Affected units may cause delayed treatment or skin redness.
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 Disposable NIBP Cuffs with specific reference numbers because they can incorrectly trigger heart rate alarms, potentially delaying treatment, and may have rough edges causing skin irritation. These issues could affect clinical use and patient safety.
The ECG electrode assembly might misread normal heart rates as dangerous conditions, causing false alarms that distract clinicians from real emergencies. Rough edges on some blood pressure cuffs can cause skin irritation or redness, especially with repeated use.
Healthcare professionals using the Radius VSM Cuffs for blood pressure monitoring are most at risk, as incorrect alarms could delay critical patient care. Patients using these cuffs for home monitoring may also experience skin irritation.
Check for the reference numbers 4825 or 4826 on the cuff packaging or label. The specific lot codes listed in the recall notice include combinations like 4825/00843997006989/21G6S and 4826/10843997006993/21HVX.
Look for reference numbers 4825 or 4826 on the cuff packaging or label.
The recall is due to two issues: the ECG electrode assembly may incorrectly detect heart rate problems, potentially delaying treatment, and some cuffs have rough edges that can cause skin irritation.
The recall record does not specify a remedy, so check the reference numbers and contact Masimo for further instructions.
Yes, the ECG feature could trigger false alarms that distract clinicians from real emergencies, and rough edges might cause skin irritation or redness.
We’ve drafted a message you can send Masimo to request your refund or repair — edit it as you like.
Subject: Recall Z-2671-2026 — Masimo Masimo Hello, I own a Masimo that is covered by recall Z-2671-2026 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.
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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.
