CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Radius VSM Disposable NIBP Cuff recalled by Masimo
Masimo is recalling Radius VSM Disposable NIBP Cuff, distributed nationwide in the US. The recall was initiated on 20 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2671-2026
- FDA event ID
- 98481
- Recalling firm
- Masimo, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2026
- FDA classified
- 2 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2026 | Recall initiated by company | |
| 2 Jul 2026 | Classified by FDA | +132 days |
| 8 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Where it was distributed
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.
Nationwide CaliforniaMassachusettsMarylandMinnesotaNorth CarolinaNew YorkOhioPennsylvaniaTennesseeTexasUtahVirginia
Questions about this recall
Why was it 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.
Which lots are affected?
REF/UDI-DI/Lot: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD; 4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98481This product is part of a recall event; the main page for the event is Radius VSM ECG pre-connected Set recalled by Masimo.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Radius VSM ECG pre-connected Set recalled by Masimo | Masimo | Device Malfunction | Nationwide |
More recalls from Masimo
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Radius VSM ECG pre-connected Set recalled by Masimo | Masimo | Device Malfunction | Nationwide |
| Device | CLASS II | Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo | Masimo | Other | Nationwide |
| Device | CLASS II | Rad-G, Pulse Oximeter with temperature (W/Sensor) recalled by Masimo | Masimo | Temperature Abuse | Nationwide |
| Device | CLASS II | Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo | Masimo | Other | Nationwide |
| Device | CLASS II | Lnop Tc-i SpO2, Reusable Ear Sensor recalled by Masimo | Masimo | Device Malfunction | 52 states |
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