Quick Facts at a Glance
- Recall Date
- February 20, 2026
- Hazard Level
- HIGH
- Brand
- Masimo
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Masimo
- Model numbers
- REF/UDI-DI/Lot: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 20, 2026
Reported by FDA DEVICE
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Masimo Corporation or your healthcare provider for instructions. Notification method: Letter
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Full Description
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826. Reason: 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.. Classification: Class II. Quantity: 1,028. Distribution: Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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