EverFlo EVERFLO w/O2 Percentage Indicator, 220V, LA, BRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959032538), received between May 11, 2023 and Aug 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438847 ↗
• MalfunctionMay 11, 2023Fire; Fire

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING OF A THERMAL EVENT TO AN EVERFLO DEVICE. THE USER ALLEGES THE DEVICE CAUGHT ON FIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.  THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911071 ↗