Masimo recalls
3 official recalls and safety alerts involving Masimo since 2023-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Masimo or the relevant agency.
- 2026-07-08
USMasimo Corporation recalls Radius VSM ECG pre-connected Set, REF: 4842, 4695
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…
FDA · DeviceMasimo CorporationWorldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY…Official notice →- 2024-04-24
- US
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
FDA · DeviceMasimo CorporationWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2023-06-28
- US
Masimo Corporation recalls Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
TC-I tip clip sensor may produce readings outside the accuracy specification.
FDA · DeviceMasimo CorporationUS: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →