EverFlo EVERFLO, 120V, UltraFill, USRecalls & reported problems
Respironics, Inc. · EVERFLO, 120V, UltraFill, US · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959032668), received between Jan 5, 2018 and Jan 5, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH, MW5073861, ALLEGING A NASAL CANNULA BEING USED WITH AN EVERFLO OXYGEN CONCENTRATOR CAUGHT FIRE WHILE THE PATIENT WAS COOKING ON AN ELECTRIC STOVE. THE PATIENT RECEIVED BURNS TO HER FACE AND WAS ADMITTED TO THE HOSPITAL 3 DAYS LATER. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THE DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATED THERE WAS NO EVIDENCE OF DAMAGE TO THE DEVICE. THE DME TESTED THE DEVICE AND THE DEVICE PASSED ALL TESTING AND WAS PLACED BACK IN THE FIELD. PRODUCT LABELING STATES,"OXYGEN VIGOROUSLY ACCELERATES COMBUSTION AND SHOULD BE KEPT AWAY FROM HEAT OR OPEN FLAME. NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. DO NOT SMOKE, ALLOW OTHERS TO SMOKE OR HAVE OPEN FLAMES NEAR THE CONCENTRATOR WHEN IT IS IN USE."
Patient problems: Burn(s)
MAUDE report 7168575 ↗
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