Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

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 Disposable NIBP Cuff
  • REF
    • 4825
    • 4826
Lot codes and dates

2 of 2 products · 24 lot codes

Recalled lot codes, grouped by product number
REFUDI-DILot
482500843997006989
  • 21G6S
  • 22JHV
  • 23H03
  • 23J05
  • 24DBV
  • 24NGG
  • 25ADG
  • E21D31
  • E21JWM
  • E23FVD
482610843997006993
  • 21HVX
  • 22ELB
  • 23G31
  • 23H04
  • 23HWL
  • 23J06
  • 24DBW
  • 24MNP
  • 24NGF
  • 25ADF
  • E21D32
  • E21F04
  • E21JFA
  • E21KHK
Amount recalled
1,028

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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 5:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.