EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V, L.ARecalls & reported problems
Respironics, Inc. · EverFlo with OPI, 120V, L.A. · Class 2
All models of EverFlo (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959032514), received between Dec 15, 2017 and Sep 29, 2021 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Device Operational Issue1
- Fire1
Patient problems
- Death1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2021Fire; Fire
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUGHT ON FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12546540 ↗DeathDec 15, 2017Device Operates Differently Than Expected; Device Operational Issue; Device Operational Issue
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR WAS NOT WORKING PROPERLY AND THE PATIENT EXPIRED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.
Patient problems: Death
MAUDE report 7121116 ↗
Other Generator, oxygen, portable devices
- DeVilbiss 525DSDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls14 deaths287 reports
- Inogen One G5 Oxygen Concentrator - Bluetooth 1260 BluetoothInogen, Inc. · Generator, Oxygen, Portable3 deaths235 reports
- EverFlo EverFlo w/O2 Percentage Indicator, 230V, EURespironics, Inc. · Generator, oxygen, portable5 deaths112 reports
- Inogen One G3 Oxygen Concentrator 1050Inogen, Inc. · Generator, Oxygen, Portable2 deaths111 reports
- DeVilbiss 125DDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls1 death3 reports
- EverFlo EVERFLO NON-O2 Percentage Indicator, 120V, US,CARespironics, Inc. · Generator, oxygen, portable19 deaths80 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V US, CARespironics, Inc. · Generator, oxygen, portable2 deaths71 reports
- SimplyGo Mini SimplyGo Mini, USRespironics, Inc. · Generator, oxygen, portable1 recall1 death5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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