Irvine, CA, United States
Masimo Corporation recalls
3 recalls recorded since 2018, most recently on 20 February 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 February 2026
- Reason
- 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.
- Distribution
- 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 R
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2670-2026, Z-2671-2026
- Radius VSM ECG pre-connected Set, REF: 4842, 4695
- Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Ongoing Class II Medical devices
- Recall started
- 15 February 2024
- Reason
- Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Aus
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1537-2024, Z-1539-2024, Z-1536-2024, Z-1538-2024
- Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
- Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
- Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
- Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Ongoing Class II Medical devices
- Recall started
- 21 April 2023
- Reason
- TC-I tip clip sensor may produce readings outside the accuracy specification.
- Distribution
- US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Co
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1986-2023, Z-1983-2023, Z-1985-2023, Z-1984-2023
- Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
- Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
- Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
- Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.