FDA recall, , Moderate risk
Masimo Radius VSM ECG Sets and NIBP Cuffs
Radius VSM ECG pre-connected Set and Disposable NIBP Cuff may have issues that could delay treatment or cause skin irritation.
Summary by Recall Canary from the FDA notice
What happened
Masimo Corporation of Irvine, California recalled the Radius VSM ECG pre-connected Set and Radius VSM Disposable NIBP Cuff. The ECG electrode assembly 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. Small and medium size blood pressure cuffs may contain rough edges, which may result in skin irritation or redness.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Radius VSM ECG pre-connected Set, REF: 4842, 4695
- UDI-DI
- 10843997011003
- 10843997016015
- Lot code
- 4842
- 25AJH
- 25KMA
- 25MSC
- 4695
- 24N17
- 25BBJ
- 25DMH
- 25FBR
- 24KLV
- 25AGZ
- 25D10
- 25GJM
- 25KBF
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
- UDI-DI
- 00843997006989
- 10843997006993
- Lot code
- 4825
- 21G6S
- 22JHV
- 23H03
- 23J05
- 24DBV
- 24NGG
- 25ADG
- E21D31
- E21JWM
- E23FVD
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Oklahoma, California , Maryland , Massachusetts , New York , Utah , North Carolina , Tennessee , Minnesota , Texas , Ohio , Pennsylvania , Virginia 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.
- Company
- Masimo CorporationIrvine, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98481
- Recall numbers
- Z-2670-2026 to Z-2671-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
