Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Masimo medical devices: approvals, recalls and adverse events

Stock: MASI. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

113

De Novo: 2

PMA approvals

0 supplements

Recalled products

0 class I

Adverse event reports

8,015

111 deaths reported

How many recalls does Masimo have?

Masimo has 16 recalled medical device products in 9 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Feb 20, 2026. In 2024 it had 4 recalled products.

How many medical devices has Masimo had cleared or approved?

113 510(k) clearances, 2 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Aug 12, 2026.

How many adverse event reports name Masimo devices?

8,015 reports in total: 111 deaths, 238 injuries and 7,597 malfunctions were reported. 193 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	3	0	0	0
2025	3	0	0	0
2024	3	0	0	0
2023

Newest clearances and approvals

Masimo Root Monitoring System
K253417 · 510(k) clearance · Aug 12, 2026
SedLine Sedation Monitor
K260880 · 510(k) clearance · Jul 10, 2026
Radius VSM and Accessories
K254209 · 510(k) clearance · Jun 4, 2026
Masimo O3 Regional Oximeter
K243324 · 510(k) clearance · Jul 17, 2025
Radius VSM and Accessories
K250757 · 510(k) clearance · May 29, 2025
Masimo W1
K243305 · 510(k) clearance · Apr 3, 2025
Masimo W1
K240229 · 510(k) clearance · Aug 8, 2024
Masimo Stork
K234021 · 510(k) clearance · May 3, 2024
MightySat -OTC
K214115 · 510(k) clearance · Jan 31, 2024
Masimo Stork
K223721 · 510(k) clearance · Dec 15, 2023
Masimo W1
K232512 · 510(k) clearance · Nov 17, 2023
ORi
DEN200076 · De Novo grant · Oct 12, 2023
Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

Devices with the most adverse event reports

By product code, all years

Oximeter (DQA, class 2)6,798
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI, class 2)914
Oximeter, Tissue Saturation (MUD, class 2)84
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK, class 2)77
Full-Montage Standard Electroencephalograph (GWQ, class 2)49
Index-Generating Electroencephalograph Software (OLW, class 2)26
System, Network And Communication, Physiological Monitors (MSX, class 2)22
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX, class 2)13
Continuous Measurement Thermometer (FLL, class 2)

All device makers and procedures · MASI stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to MASI with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	2	585	5
2025	0	193	2
2024	4	180	-
2023	4	333	3
2022	0	302	-
2021	0	318	1
2020	0	226	3
2019	0	467	1
2018	0	603	4
2017	0	1,117	7
2016	0	1,478	14
2015	1	1,496	29
2014	1	611	38
2013	1	30	-
2012	0	6	-

Newest recalls

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Class II · Feb 20, 2026 · Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on no
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Class II · Feb 20, 2026 · Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on no
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Class II · Feb 15, 2024 · Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Class II · Feb 15, 2024 · Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Class II · Feb 15, 2024 · Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Class II · Feb 15, 2024 · Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Class II · Apr 21, 2023 · TC-I tip clip sensor may produce readings outside the accuracy specification.
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Class II · Apr 21, 2023 · TC-I tip clip sensor may produce readings outside the accuracy specification.
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Class II · Apr 21, 2023 · TC-I tip clip sensor may produce readings outside the accuracy specification.
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Class II · Apr 21, 2023 · TC-I tip clip sensor may produce readings outside the accuracy specification.