Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Masimo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Masimo Corporation · 52 Discovery · Irvine, CA · 92618-3105
Is this the product you have?
- Radius VSM ECG pre-connected Set
- REF
48424695
- Lot codes and dates
- REF/UDI-DI/Lot
4842/10843997011003/25AJH25KMA25MSC 4695/10843997016015/24N1725BBJ25DMH25FBR24KLV24N1725AGZ25BBJ25D1025DMH25FBR25GJM25KBF
- REF/UDI-DI/Lot
- Amount recalled
- 772
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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