EverFlo EVERFLO w/Oxygen Percentage Indicator, 230V, HKRecalls & reported problems
Respironics, Inc. · EVERFLO w/Oxygen Percentage Indicator, 230V, Hong Kong · Class 2
All models of EverFlo (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959032644), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Electrical /Electronic Property Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2018Electrical /Electronic Property Problem; Break; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR HAD THERMAL DAMAGE TO THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE EVALUATED BY THE MANUFACTURER'S SERVICE CENTER. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7365715 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page