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Masimo Corporation FDA Recalls
10 recalls on file across devices, 0 of them Class I and 10 still open. Matched by name to MASI.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Radius VSM Disposable NIBP Cuff, REF: 4825, 4826Class IIFeb 20, 2026Two devices recalled: 1) Electrocardiogram (ECG) electrode a |
| Radius VSM ECG pre-connected Set, REF: 4842, 4695Class IIFeb 20, 2026Two devices recalled: 1) Electrocardiogram (ECG) electrode a |
| Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Class IIFeb 15, 2024Their is a potential that Oximeter may automatically power o |
| Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Class IIFeb 15, 2024Their is a potential that Oximeter may automatically power o |
| Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Class IIFeb 15, 2024Their is a potential that Oximeter may automatically power o |
| Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,Class IIFeb 15, 2024Their is a potential that Oximeter may automatically power o |
| Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794Class IIApr 21, 2023TC-I tip clip sensor may produce readings outside the accu |
| Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895Class IIApr 21, 2023TC-I tip clip sensor may produce readings outside the accu |
| Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053Class IIApr 21, 2023TC-I tip clip sensor may produce readings outside the accu |
| Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503Class IIApr 21, 2023TC-I tip clip sensor may produce readings outside the accu |