Masimo Corporation
Active in EUDAMED VerifiedUnited Statesclaimed EUDAMED FDA SRN US-MF-000010641 FEI 3011353843
- Devices
- 1,092
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1610 ongoing
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MDSS GmbHDE
What Masimo Corporation makes
Masimo Corporation manufactures reusable electrical connection cables for medical devices, single-use and reusable pulse oximeter probes, and gas-sampling respiratory tubing for CO₂ monitoring. Their portfolio also includes pulse co-oximeters and reusable/single-use probes for these devices, as well as non-silicone adhesive tape for securing dressings. Examples include fingertip and infant pulse oximeters, nasal/oral CO₂ cannulas, and airway adapter sets for respiratory support.
The company’s devices are classified under Class I, Class II, and Class IIb regulations. Their products are listed in the EU’s eudamed registry and the FDA’s UDI database. The manufacturer is based in the United States.
Catalogue
Search and filter all 1,092 devicesShowing 1-50 of 1,092
Company details
- EUDAMED SRN
- US-MF-000010641
- FDA FEI number
- 3011353843
- DUNS number
- 780421038
- EUDAMED status
- Active
- EUDAMED registered name
- Masimo Corporation
- Registered address
- 52, Discovery, 92618, Irvine, United States
- Website
- www.masimo.com
- Phone
- +1 (949) 297-7000
- PRRC contact
- Mathew Jimenez
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 29 Apr 2028
Intertek Medical Notified Body AB 2862 1 certificate
- 28620149254-03 Active
Quality management system EU MDR
- Issued
- 18 Dec 2023
- Expires
- 29 Apr 2028
- Reason
- Add device or group
FDA recalls
FDA recall records list 16 recalls initiated by MASIMO CORPORATION, the earliest on 2005-06-10 and the most recent on 2026-02-20. By recorded status: 10 ongoing and 6 terminated. The reasons filed fall into these groups: electrical or power, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 4
- 2024 4
- 2025 0
- 2026 2
2026
- 20 Feb 2026 Z-2670-2026 Class II Ongoing 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 treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Full distribution text
- 20 Feb 2026 Z-2671-2026 Class II Ongoing 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 treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Full distribution text
- 20 Feb 2026 Z-2670-2026 Class II Ongoing 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 treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
2024
- 15 Feb 2024 Z-1536-2024 Class II Ongoing Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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- 15 Feb 2024 Z-1537-2024 Class II Ongoing Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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- 15 Feb 2024 Z-1538-2024 Class II Ongoing Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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- 15 Feb 2024 Z-1539-2024 Class II Ongoing Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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- 15 Feb 2024 Z-1536-2024 Class II Ongoing Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
2023
- 21 Apr 2023 Z-1983-2023 Class II Ongoing TC-I tip clip sensor may produce readings outside the accuracy specification.
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- 21 Apr 2023 Z-1984-2023 Class II Ongoing TC-I tip clip sensor may produce readings outside the accuracy specification.
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- 21 Apr 2023 Z-1985-2023 Class II Ongoing TC-I tip clip sensor may produce readings outside the accuracy specification.
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- 21 Apr 2023 Z-1986-2023 Class II Ongoing TC-I tip clip sensor may produce readings outside the accuracy specification.
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- 21 Apr 2023 Z-1983-2023 Class II Ongoing TC-I tip clip sensor may produce readings outside the accuracy specification.
Show all 16 recalls
2015
- 28 Oct 2015 Z-0338-2016 Class II Terminated 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.
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- 28 Oct 2015 Z-0338-2016 Class II Terminated 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.
2014
- 30 Sep 2014 Z-0213-2015 Class II Terminated 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 value is measured, a low SpO2 value would be displayed on the monitoring device.
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- 30 Sep 2014 Z-0213-2015 Class II Terminated 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 value is measured, a low SpO2 value would be displayed on the monitoring device.
2013
- 13 Mar 2013 Z-1187-2013 Class II Terminated 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.
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- 13 Mar 2013 Z-1187-2013 Class II Terminated 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.
2010
- 23 Dec 2010 Z-1387-2011 Unclassified (pre-2012) Terminated Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oximeter may provide an incorrect SpHb measurement.
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- 23 Dec 2010 Z-1387-2011 Unclassified (pre-2012) Terminated Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oximeter may provide an incorrect SpHb measurement.
2006
- 2 Feb 2006 Z-0661-06 Unclassified (pre-2012) Terminated Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
Full distribution text
- 2 Feb 2006 Z-0661-06 Unclassified (pre-2012) Terminated Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
2005
- 10 Jun 2005 Z-0933-05 Unclassified (pre-2012) Terminated Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
Full distribution text
- 10 Jun 2005 Z-0933-05 Unclassified (pre-2012) Terminated Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
About
Masimo is a global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies, medical devices, and a wide array of sensors. The company's mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. Best known for its Signal Extraction Technology (SET) pulse oximetry, Masimo also produces devices for measuring blood oxygen saturation, pulse rate, perfusion index, pleth variability index, and total haemoglobin. Headquartered in Irvine, California, with 9,000+ employees worldwide.
Frequently asked questions
How many devices does MASIMO CORPORATION have in the registry?
The registry currently lists 1092 devices for MASIMO CORPORATION. Devices recorded under merged duplicate company entries are counted once.
Which registries list MASIMO CORPORATION's devices?
Among its 50 most recently registered devices, MASIMO CORPORATION has devices listed in EUDAMED (46 devices), FDA 510(k) (4 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MASIMO CORPORATION's devices fall under?
Among its 50 most recently registered devices, the classes recorded for MASIMO CORPORATION's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for MASIMO CORPORATION?
FDA recall records list 16 recalls initiated by MASIMO CORPORATION, the most recent initiated on 20 Feb 2026. 10 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for MASIMO CORPORATION?
EUDAMED lists 1 certificate for MASIMO CORPORATION (quality management system) under MDR. The most recent was issued on 18 Dec 2023.
What are the newest devices from MASIMO CORPORATION in the registry?
The most recently registered devices listed for MASIMO CORPORATION include smartSET Adt-L CS-3, uSpO2 Masimo SET Oximetry Cable, USB, Masimo SafetyNet and RD rainbow SET R25-04, EMS.