Masimo Corporation

FDA recalling firm · 6 enforcement events · 13 product records · 2013–2026 · CA

Masimo Corporation has 6 FDA enforcement events on this register (13 product records) between 2013 and 2026: 6 device; the busiest year was 2013 with 1.

0% of its events are Class I; the most common class is Class II (6). 3 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
20 Feb 2026	Radius VSM ECG pre-connected Set, REF: 4842, 4695	Device	Class II	2	Ongoing
15 Feb 2024	Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,	Device	Class II	4	Ongoing
21 Apr 2023	Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053	Device	Class II	4	Ongoing
28 Oct 2015	rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of…	Device	Class II	1	Terminated
30 Sep 2014	Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped…	Device	Class II	1	Terminated
13 Mar 2013	Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).	Device	Class II	1	Terminated

By type and class

Device6

Class II6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Masimo Corporation by year initiated.

Questions and answers

How many FDA recalls has Masimo Corporation had?

6 enforcement events (13 product records) on this register, 2013–2026: 6 device.

Are any Masimo Corporation recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Masimo Corporation recalls?

6 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.