Facility

MASIMO CORPORATION

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009831876
Establishment type	Repack or Relabel Medical Device
Location	9600 Jeronimo Irvine, CA, US 92618
Registration status	Active · expires 2026
Parent company	MASIMO CORPORATION (owner-operator 9031881)
Brand names	Radius VSM RAS-45; Radius VSM and Accessories

Activity by year

Recalls (6)

Devices registered here (13)

Computer, Diagnostic, Programmable
Product code DQK (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1425
Oximeter, Ear
Product code DPZ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2710
Continuous Measurement Thermometer
Product code FLL (opens in a new tab) · Class II · General Hospital · 21 CFR 880.2910
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Product code DRT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2300
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code MHX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025
Monitor, Breathing Frequency
Product code BZQ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2375
Blood Pressure Cuff
Product code DXQ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1120
Alarm, Blood-Pressure
Product code DSJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1100
Monitor, Bed Patient
Product code KMI (opens in a new tab) · Class I · General Hospital · 21 CFR 880.2400
Oximeter
Product code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700
System, Measurement, Blood-Pressure, Non-Invasive
Product code DXN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1130
Detector And Alarm, Arrhythmia
Product code DSI (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025
Electrocardiograph
Product code DPS (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2340

Recalls & enforcement

Class IIOngoing2026-02-20
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 …
Class IIOngoing2024-02-15
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class IIOngoing2023-04-21
TC-I tip clip sensor may produce readings outside the accuracy specification.
Class IITerminated2015-10-28
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
Class IITerminated2014-09-30
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 valu…
Class IITerminated2013-03-13
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MASIMO CORPORATION (FEI 3009831876) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009831876-masimo-corporation/

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