EverFlo EVERFLO NON-O2 Percentage Indicator, 120V, US,CARecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00606959014954), received between Sep 28, 2016 and Mar 25, 2026 — classified as 19 deaths, 24 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fire” (19 reports).

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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Fire; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED AN EXPLOSION WHILE USING AN EVERFLO DEVICE. THE DEVICE SETTINGS DURING THE EVENT WERE REPORTED TO ARE UNKNOWN. DURING THE EVENT, THE PATIENT'S BEARD CAUGHT FIRE, AND HIS NOSE, EARS, AND FACE WERE BURNED. THE PATIENT HAS NOT RECEIVED MEDICAL INTERVENTION. THE PATIENT APPLIED ZINC OINTMENT, AND WOUNDS ARE FESTERING. PATIENT IS ALSO HAVING TROUBLE SEEING AND HEARING. THE EVERFLO DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Burn(s)

  MAUDE report 24687210 ↗
• MalfunctionJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED ASTHMA ATTACK WHILE USING AN EVERFLO DEVICE. THE DEVICE SETTINGS DURING THE EVENT WERE REPORTED TO BE UNKNOWN. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Asthma

  MAUDE report 24186020 ↗
• DeathJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION REPORTING A PATIENT WITH A EVERFLO DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092608 ↗
• MalfunctionDec 15, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE EVERFLO DEVICE HAS ISSUES WITH POWER CORD AND INTEGRATED CANISTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THE POWER CORD MELTED AT ONE END AND SIEVE COLUMNS WERE FAILING. THE DEVICE POWER CORD AND SIEVE COLUMNS WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810621 ↗
• MalfunctionDec 8, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PC BOARD BURNT AND NOT TURNING ON. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752433 ↗
• MalfunctionOct 24, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO EVERFLO DEVICE THAT THE DEVICE WAS SERVICED BY THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN CONFIRMED THAT THE DEVICE'S BOARD FAN CONNECTOR WAS BURNT, AND THE COMPRESSOR WAS TOO LOUD/NOISY. THE DEVICES PCA, ROHS, EVERFLO W LCD, DOM, COMPRESSOR NEED TO BE REPLACED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383422 ↗
• MalfunctionJul 28, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN EVERFLO PORTABLE OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING INSPECTION, THE SERVICE TECHNICIAN REPORTS FINDING A BURNED PCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630589 ↗
• MalfunctionJun 16, 2025Fire; Melted; Fire; Melted

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN EVERFLO PORTABLE OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE TECHNICIAN ALLEGES EXTERNAL FIRE DAMAGE, THERMAL EVENT TO PATIENT TUBING, CUSTOMER UNSURE IF DEVICE CAUSED FIRE. THEN THE EVALUATION SHOWS THAT THE FIRE WAS EXTERNAL, ALL EVIDENCE INDICATIVE OF PATIENT USE/ORIGINATING EXTERNAL TO UNIT DESIGN. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS SENT TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION, A BURNT HUMIDIFIER BASE CABLE WAS FOUND. THE THIRD PARTY SERVICE CENTER WAS UNABLE TO COMPLETE THE INVESTIGATION, AND THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY AND INVESTIGATED FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212773 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (B)(4). THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT ALLEGING 2ND DEGREE BURNS TO HIS FACE RIGHT OF NOSE, RIGHT UPPER LIP, AND BILATERAL NOSTRILS. THE PATIENT LIT A CIGARETTE WHILE OXYGEN WAS IN USE. THE INSTRUCTION FOR USE WARNING STATES, "DO NOT SMOKE, ALLOW OTHERS TO SMOKE, OR HAVE OPEN FLAMES NEAR THE CONCENTRATOR WHEN IT IS IN USE. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH." NO OTHER MEDICAL INFORMATION OR INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22012234 ↗
• MalfunctionMar 19, 2025Failure to Power Up; Failure to Power Up

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO DOM NON THAT ALLEGES DEVICE DOESN'T TURN POWER ON FOR MAIN PCB WITH CONNECTOR BURNED. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646224 ↗
• DeathFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT PASSED AWAY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 21402615 ↗
• DeathFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER HAS BEEN INFORMED OF THE PASSING OF A PATIENT WHO WAS USING AN EVERLO OXYGEN CONCENTRATOR. THE CAREGIVER WAS REQUESTING TO RETURN THE DEVICE. NO FURTHER DETAILS WERE PROVIDED, AND THERE HAS BEEN NO INDICATION THAT THE DEVICE PLAYED A ROLE IN THE PATIENT'S DEATH. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 21401927 ↗
• DeathFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER HAS BEEN INFORMED OF THE PASSING OF A PATIENT WHO WAS USING AN EVERFLO PORTABLE OXYGEN CONCENTRATOR. THE USER'S HUSBAND CALLED IN TO STATE HIS WIFE HAD PASSED AWAY AND SHE HAD AN EVERFLO DEVICE THAT HAD ORIGINALLY BELONGED TO HER MOTHER AND WAS UNSURE WHAT TO DO WITH THE DEVICE. NO FURTHER DETAILS WERE PROVIDED, AND THERE HAS BEEN NO INDICATION THAT THE DEVICE PLAYED A ROLE IN THE PATIENT'S DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 21312989 ↗
• InjuryJan 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ASTHMA. THERE WAS A REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma

  MAUDE report 21171581 ↗
• InjuryJan 14, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A EVERFLO. THE MANUFACTURER RECEIVED INFORMATION ALLEGING CANCER WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Cancer

  MAUDE report 21151485 ↗
• InjuryDec 13, 2024Fire; Improper or Incorrect Procedure or Method; Fire; Improper or Incorrect Procedure or Method

  THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (120535-2024-0001) IN REFERENCE TO AN EVERFLO OXYGEN CONCENTRATOR. THE USER WAS SMOKING IN BED WHILE USING THE EVERFLO OXYGEN CONCENTRATOR ON (B)(6) 2024, RESULTING IN IGNITION (UNSPECIFIED FUEL SOURCE). THE PATENT'S GRANDDAUGHTER WAS REPORTED TO HAVE SMOTHERED THE FIRE WITH A BLANKET. THE FOLLOWING DAY THE PATIENT'S HOMECARE NURSE ASSESSED THE PATIENT NOTING RIGHT UPPER THIGH AND NASAL BURNS (REPORTED 2ND DEGREE). FURTHER MEDICAL EVALUATION VIA EMS WAS DECLINED AND THE PATIENT WAS REPORTED TO HAVE RECEIVED TRIPLE ANTIBIOTIC OINTMENT FOR THE WOUNDS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20925088 ↗
• MalfunctionOct 22, 2024Fire; Fire

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT HAD SMELLED SOMETHING BURNING AND THE NURSES TOOK THE DEVICE OFF BEFORE IT CAUGHT FIRE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED AS REQUIRED BY THE PATIENT. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502089 ↗
• DeathSep 25, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS INVOLVED IN A HOUSE FIRE. BC1 ARRIVED ON SCENE OF WORKING FIRE INVOLVING A SINGLE-STORY RESIDENTIAL STRUCTURE. IT WAS REPORTED THE PATIENT'S BODY WAS FOUND IN THE HOME AFTER THE FIRE WAS CONTROLLED. THE PATIENT IS REPORTED TO HAVE UNDIAGNOSED DEMENTIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305944 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING EVERFLO DEVICE. THE PATIENT HAS ALLEGED EYE IRRITATION; DIZZINESS AND/OR HEADACHE, ASTHMA (NEW OR WORSENING). MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma; Dizziness; Eye Irritation; Headache

  MAUDE report 20305388 ↗
• DeathSep 11, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A PHILIPS CPAP DEVICE SOUND ABATEMENT FOAM. THE PATIENT HAS PASSED AWAY. 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 20191815 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO THAT THE PATIENT ALLEGES RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, INFLAMMATORY RESPONSE AND KIDNEY DISEASE/TOXICITY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dizziness; Headache; Inflammation; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 19925291 ↗
• MalfunctionAug 4, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER WAS CONTACTED ABOUT AN EVERFLO DEVICE ALLEGING THAT THE DEVICE IS ALARMING, AND THE PATIENT IS OUT OF BREATH; THERE IS NO ALLEGATION THAT THE DEVICE HAS CAUSED ANY HARM, AND NEITHER WAS MEDICAL INTERVENTION MENTIONED. THE PATIENT WAS DIRECTED TO CONTACT THE DME/FASC. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dyspnea

  MAUDE report 19903382 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ASTHMA (NEW OR WORSENING). MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma

  MAUDE report 19697863 ↗
• DeathJul 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A EVERFLO DEVICE. THERE WAS AN ALLEGATION OF PATIENT DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 19654168 ↗
• DeathJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A EVERFLO DOM NON- OPI DEVICE. THE PATIENT HAS ALLEGEDLY PASSED AWAY. NO MEDICAL INTERVENTION WAS REPORTED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 19632098 ↗