RegWardenFDA facility compliance records
Company

MASIMO CORPORATION

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2026: 1 recalls1’131’141’15’16’17’18’19’20’21’221’231’24’251’26
  • Recalls (6)

Registered facilities (6)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “MASIMO CORPORATION — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9031881-masimo-corporation/

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