FDA DevicesClass II
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Published: July 8, 2026Recall ID: Z-2671-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Additional Source Details
| Field | Value |
|---|---|
| City | Irvine |
| State | CA |
| Event id | 98481 |
| Address 1 | 52 Discovery |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 92618-3105 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 1,028 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260220 |
| Initial firm notification | Letter |
| Center classification date | 20260702 |
Overview
- Recalling FirmMasimo Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.