EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V US, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00606959022041), received between Feb 8, 2018 and Sep 16, 2026 — classified as 2 deaths, 9 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (14 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Thermal Decomposition of Device; Overheating of Device

  The manufacturer received a work order on an Everflo device. During the evaluation, the technician noted blown sieves, melted covers, and cracked flow control. The problem was able to be duplicated due to case full of sieve dust. Foam was also observed at the exhaust port, blocking air flow resulting in overheating and melted covers.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794609 ↗
• MalfunctionSep 1, 2026Thermal Decomposition of Device

  The manufacturer received a work order on an EverFlo device. During evaluation the technician noted front case melted. The technician noted that the faulty sieve canister assembly was the confirmed cause.Additionally unrelated to the reportable malfunction It was noted that a bad compressor caused low purity, and a faulty board caused the alarms not to be audible.In conclusion it was noted that the Sieve Canister, compressor, circuit board, front case, and the flow meter need to be replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546503 ↗
• MalfunctionAug 24, 2026Thermal Decomposition of Device

  The manufacturer received information from a work order on an EverFlo 120V OPI Domestic device. Per work order received, the device was alarming, no loss of power alarm, noisy compressor, low purity of 20.9%, cases "melted", and cracked flow control. The problem was able to be duplicated due to faulty board causing audible loss of power alarm, faulty sieve assembly causing low purity and alarming, faulty compressor specs of 12lpm causing low purity and alarming, and foam blocked exhaust port causing overheating and melted cases. 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 50398546 ↗
• MalfunctionAug 11, 2026Thermal Decomposition of Device

  The manufacturer received information alleging that the device has a power cord damage, PCA short and will not start up. The sieve leak is producing low 02, inlet is dirty, compressor plugs and manifold melted out. There was no report of serious or permanent harm or injury. There was no report of medical intervention.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216603 ↗
• MalfunctionMar 11, 2026Melted

  THE EVERFLO DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND THE DEVICE HAD MELTED COVERS, AND IT WAS FOUND THAT THE FOAM ABOVE THE EXHAUST PORT CAME UNGLUED AND BLOCKED THE EXHAUST WHICH CAUSED OVERHEATING, MELTING THE COVERS. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE DEVICE WAS ALARMING AND EXHIBITED BLOWN SIEVES AND LOW PURITY OF 49%. THE TECHNICIAN WAS ABLE TO DUPLICATE PROBLEM DUE TO CASE FULL OF SIEVE DUST; FAULTY COMPRESSOR SPECS OF 17 LPM@20 PSI, CAUSING LOW PURITY AND ALARMING. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575645 ↗
• MalfunctionMar 10, 2026Electrical /Electronic Property Problem; Temperature Problem

  A EVERFLO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE SERVICE OBSERVED PCA SHORT CIRCUIT - FUSE AND RESISTOR BLOWN. REPLACED PCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563959 ↗
• MalfunctionJan 13, 2026Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE EVERFLO DEVICE HAS ISSUES WITH LOW PURITY. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THE COVER WAS MELTED AND DUE TO FAULTY SIEVE VALVE ASSEMBLY CAUSING LOW PURITY. ADDITIONALLY, INTEGRATED CANISTER, FRONT CABINET, REAR CABINET, AND FLOWMETER WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24062090 ↗
• MalfunctionJan 13, 2026Thermal Decomposition of Device; Melted

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE EVERFLO DEVICE HAS ISSUES WITH LOW PURITY AND DEVICE EXHIBITED ALARM. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THE COVER IS MELTED AND DUE TO FAULTY SIEVE VALVE ASSEMBLY CAUSING LOW PURITY AND ALARMING. ADDITIONALLY, INTEGRATED CANISTER, REAR CABINET AND FRONT CABINET WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24062089 ↗
• MalfunctionNov 4, 2025Thermal Decomposition of Device; Overheating of Device; Thermal Decomposition of Device; Overheating of Device

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND FOAM ABOVE EXHAUST PORT CAME LOOSE FROM INSUFFICIENT ADHESIVE BLOCKING EXHAUST AND CAUSING OVERHEATING AND MELTED COVERS. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466254 ↗
• MalfunctionOct 30, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD-PARTY SERVICE CENTER WORK ORDER WHICH ALLEGED A BURNT PC (PRINTED CIRCUIT) BOARD AND BLOWN SIEVE OCCURRED ON AN EVERFLO 120V OPI. THERE WAS NO DEATH, SERIOUS HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424224 ↗
• MalfunctionOct 27, 2025Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE EVERFLO DEVICE THE BACK CABINET INNER STRUCTURE IS CRACKED, THE SIEVE BEDS ARE WEAK, PCA FUSE IS BURNT OUT. BACK CABINET, PCA AND SIEVE BEDS WAS REPLACED. NO DEATH. NO SERIOUS HARM OR INJURY WAS REPORTED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A PRODUCT MALFUNCTION. 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 23393074 ↗
• MalfunctionOct 24, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE EVERFLO DEVICE WAS FOUND WITH PC BOARD BURNT, SIEVE BEDS SHIFTING HARD/BAD. NO DEATH. NO SERIOUS HARM OR INJURY WAS REPORTED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A PRODUCT MALFUNCTION. 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 23386194 ↗
• MalfunctionOct 15, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE EVERFLO DEVICE WAS RETURNED TO THE SERVICE CENTER. THIS DEVICE HAS BEEN SERVICED, AND THE SERVICE TECHNICIAN FOUND BURNT MARKS AND DEFORMATION OF THE FRONT CABINET DUE TO THE PCA BURNING UP. THERE WERE ALSO SIGNS OF SIEVE DUST IN THE MACHINE. IN ADDITION, FRONT CABINET, SIEVE, INLET FILTER AND PCA NEEDS TO BE REPLACED. THERE WAS 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 23282085 ↗
• DeathJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RELATIVE OF A PATIENT INQUIRED ABOUT RETURNING A PATIENT'S DEVICE REPORTING THE PATIENT PASSED AWAY. THE PATIENT'S CAUSE OF DEATH WAS NOT PROVIDED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE REPORTER SURROUNDING THE DETAILS OF THE PATIENT'S DEATH, AND IF THERE WAS ANY KNOWN DEVICE ISSUE. 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 22506387 ↗
• MalfunctionJul 3, 2025Overheating of Device; Overheating of Device

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE MAINTENANCE OF THEIR OXYGEN CONCENTRATOR. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF A THERMAL MALFUNCTION. DURING THE EVALUATION, THE PC BOARD WAS REPORTED AS BURNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394146 ↗
• MalfunctionMay 21, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING COVERS MELTED DUE TO OVERHEATING. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061974 ↗
• MalfunctionMay 15, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING FAULTY PCA, FAULTY COMPRESSOR OVERHEATING/SHORT CIRCUIT, LOW O2 PURITY, REPLACED FILTER AND ALL FAULTY PARTS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024136 ↗
• MalfunctionNov 1, 2024Contamination; Melted; Excessive Heating; Contamination; Melted; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO AN EVERFLO PORTABLE OXYGEN CONCENTRATOR. IT IS ALLEGED THAT THE DEVICE HAS BLOWN SIEVES, MELTED CABINETS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. SERVICE TECHNICIAN REPORTS BEING ABLE TO DUPLICATE PROBLEM DUE TO CASE FULL OF SIEVE DUST; FOAM OVER EXHAUST PORT CAME LOOSE AND BLOCKED EXHAUST CAUSING OVERHEATING AND CABINETS TO MELT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591842 ↗
• MalfunctionSep 6, 2024Contamination; Insufficient Device Problem Information; Contamination; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO AN EVERFLO 120V OPI. THE USER ALLEGES THE PLASTIC PARTS WAS MELTING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 20158766 ↗
• MalfunctionAug 6, 2024Degraded; Power Problem; Degraded; Power Problem

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR AN EVERFLO OXYGEN CONCENTRATOR DUE TO TFOUND SIEVE BEDS BLOWN, PCA BOARD HAS NON-STOP ALARMING, POWER CORD CHEWED UP, FRONT CASE CRACKED, REAR CASE CRACKED. THE FAULTY PARTS WERE REPLACED. THIS REPORT IS BEING SUBMITTED DUE TO THE POWER CORD WAS CHEWED UP. 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 19924470 ↗
• MalfunctionAug 6, 2024Degraded; Overheating of Device; Degraded; Overheating of Device

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR AN EVERFLO OXYGEN CONCENTRATOR DUE TO ALARMING; CABINETS MELTED; ABLE TO DUPLICATE PROBLEM DUE TO FAULTY O2 SENSOR ON BOARD CAUSING SPORADIC HIGH O2 ALARM; FAULTY ADHESIVE ON FOAM ABOVE EXHAUST OUTLET CAUSING FOAM TO FALL AND BLOCK THE EXHAUST CAUSING THE UNIT TO OVERHEAT AND THE CABINETS TO MELT INSIDE. THIS REPORT IS BEING SUBMITTED DUE TO UNIT TO OVERHEAT AND THE CABINETS TO MELT INSIDE. 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 19924370 ↗
• MalfunctionAug 6, 2024Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO DEVICE THAT THE PATIENT ALLEGES THAT THE DEVICE IS ALARMING, AND OVERHEATING. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, THE FLOW CONTROL WAS CRACKED, FAULTY FAN CAUSING OVERHEATING AND ALARMING. 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 19923830 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO AN EVERFLO 120V OPI. THE USER ALLEGES THE DEVICE HAS LOW PURITY OF 75%, BLOWN SIEVES, MELTED CABINETS, CASE FULL OF SIEVE DUST, OVERHEATING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 19817668 ↗
• MalfunctionJun 7, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A MALFUNCTION OF A OXYGEN CONCENTRATOR. THE MANUFACTURER ALLEGING A BURNT PRONGS DUE TO DEVICE BEING PLUGGED INTO A BAD RECEPTACLE. THERE ARE NO ALLEGATIONS OF PATIENT HARM. MEDICAL INTERVENTION WAS NOT SPECIFIED. A DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF A BURNT, WARPED PRONGS DUE TO A LACK OF PREVENTATIVE MAINTENANCE/SERVICING (DUTY OF CARE) . DURING THE EVALUATION, IT WAS REPORTED THE THERMAL ISSUE WAS DUE TO USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483630 ↗
• MalfunctionMay 22, 2024Smoking; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ON EVERFLO DEVICE ALLEGING SMOKE. 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 19374935 ↗