Masimo - 15750 Alton Pkwy
FDA adverse event reports naming Masimo - 15750 Alton Pkwy as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MASIMO - 15750 ALTON PKWY.
- Total reports
- 1,369
- Deaths
- 6
- Injuries
- 5
- Malfunctions
- 1,358
Reports per year
119
10321
27922
28123
15824
18825
35926
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- OximeterDQA808
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI443
- Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK61
- Oximeter, Tissue SaturationMUD21
- Full-Montage Standard ElectroencephalographGWQ10
- Index-Generating Electroencephalograph SoftwareOLW10
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX7
- Continuous Measurement ThermometerFLL3
- Hyperoxia Monitoring Device Adjunct To Pulse OximetryQWE2
- Monitor, Breathing FrequencyBZQ1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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