The Recall Desk

Manufacturer

Masimo Corporation

13 recalls in our database name Masimo Corporation as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2026-07-08

Of the 13 recalls from Masimo Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

  • HighFDA (Devices)·Z-2670-2026·2026-07-08

    Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection

    Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.

    Product
    Radius VSM ECG pre-connected Set, REF: 4842, 4695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2671-2026·2026-07-08

    Radius VSM Disposable NIBP Cuff recalled for rough edges

    Masimo Corporation is recalling Radius VSM Disposable NIBP Cuffs (blood pressure cuffs) with lot numbers 21G6S through 25ADF because they may contain rough edges that could cause skin irritation or redness.

    Product
    Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring

    Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Risk of Automatic Power Loss

    Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter automatic power cycling may cause monitoring loss

    Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Potential Automatic Power Loss

    Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2023·2023-06-28

    Masimo SpO2 Ear Sensor May Produce Inaccurate Oxygen Saturation Readings

    Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1984-2023·2023-06-28

    Masimo LNOP TC-I Pulse Oximeter Sensor May Produce Inaccurate Readings

    Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.

    Product
    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1986-2023·2023-06-28

    Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications

    Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1983-2023·2023-06-28

    Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings

    Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.

    Product
    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0338-2016·2015-12-02

    Masimo Recalls Rainbow Reusable Sensors Due to Inaccurate Readings

    Masimo is recalling Rainbow Reusable Sensors because incompatible configurations may cause no readings or inaccurate SpCO and SpMet results.

    Product
    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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2015·2014-11-19

    Masimo SET uSpO2 Pulse Oximetry Cables Recalled for Crossed Wires

    Masimo Corporation is recalling specific SET uSpO2 Pulse Oximetry Cables due to crossed internal wires that may cause the monitoring device to display inverted SpO2 values.

    Product
    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:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1187-2013·2013-05-08

    Masimo Recalls Rad-8 Pulse Oximeters Due to Unintended Power-Off Defect

    Masimo is recalling 42,908 Rad-8 pulse oximeters worldwide because a small percentage of devices may power off unexpectedly when the patient cable is moved.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Masimo

American healthcare company

Official website

Source: Wikidata (Q6783278), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.