Masimo recalls

Masimo has 11 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 8 Jul 2026. 9 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls11since 2013

Last 12 months2reported

Class I00% of total

Ongoing9latest 8 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 2Jul 0 0

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

Why masimo is recalled

Product types

Patient Monitors655%
Other Medical Devices545%

By year

2026218%
2024327%
2023436%
201519%
201319%

Ongoing masimo recalls

9 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Radius VSM Disposable NIBP Cuff recalled by Masimo	Masimo	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Radius VSM ECG pre-connected Set recalled by Masimo	Masimo	Device Malfunction	Nationwide
24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo	Masimo	Other	Nationwide
24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter with temperature (W/Sensor) recalled by Masimo	Masimo	Temperature Abuse	Nationwide
24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo	Masimo	Other	Nationwide
28 Jun 2023Device	CLASS II	Lnop Tc-i SpO2, Reusable Ear Sensor recalled by Masimo	Masimo	Device Malfunction	52 states

All masimo recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Radius VSM Disposable NIBP Cuff recalled by Masimo	Masimo	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Radius VSM ECG pre-connected Set recalled by Masimo	Masimo	Device Malfunction	Nationwide
24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo	Masimo	Other	Nationwide
24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter with temperature (W/Sensor) recalled by Masimo	Masimo	Temperature Abuse	Nationwide
24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo	Masimo	Other	Nationwide
28 Jun 2023Device	CLASS II	Lnop Tc-i SpO2, Reusable Ear Sensor recalled by Masimo	Masimo	Device Malfunction	52 states
28 Jun 2023Device	CLASS II	Lncs Tc-i SpO2, Reusable Ear Sensor recalled by Masimo	Masimo	Device Malfunction	52 states
28 Jun 2023Device	CLASS II	RD Set TC-I SpO2 Adult Reusable Ear Sensor recalled by Masimo	Masimo	Device Malfunction	52 states
28 Jun 2023Device	CLASS II	Lncs Tc-i SpO2, Reusable Ear Sensor recalled by Masimo	Masimo	Device Malfunction	52 states
2 Dec 2015Device	CLASS II	rainbow Reusable Sensors recalled by Masimo	Masimo	Labeling Errors	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.