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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 ↗

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Sources and updates

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