EverFloRecalls & reported problems across all models
Respironics, Inc. · 20 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 381
- Deaths reported
- 45
- Injuries reported
- 70
- Recalls
- 0
We found 20 models of EverFlo by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 381 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2016 and Sep 23, 2026 — classified as 45 deaths, 70 injuries, 266 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (62 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EverFlo problems
Device problems
- Adverse Event Without Identified Device or Use Problem69
- Thermal Decomposition of Device62
- Fire54
- Overheating of Device45
- Electrical /Electronic Property Problem24
- Excessive Heating19
- Smoking15
- Use of Device Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions232
- Burn(s)35
- No Consequences Or Impact To Patient27
- Insufficient Information17
- Death13
- No Known Impact Or Consequence To Patient11
- Patient Problem/Medical Problem10
- Low Oxygen Saturation9
EverFlo models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EverFlo EverFlo w/O2 Percentage Indicator, 230V, EUGenerator, oxygen, portable5 deaths112 reports
- EverFlo EVERFLO NON-O2 Percentage Indicator, 120V, US,CAGenerator, oxygen, portable19 deaths80 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V US, CAGenerator, oxygen, portable2 deaths71 reports
- EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, IKKGenerator, oxygen, portable3 deaths42 reports
- EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, UK, IEGenerator, oxygen, portable3 deaths16 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 230V, ZAGenerator, oxygen, portable1 death13 reports
- EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, AUGenerator, oxygen, portable4 deaths12 reports
- EverFlo EVERFLO QUIET w/O2 Percent Indicator, 120V, US, CAGenerator, oxygen, portable6 reports
- EverFlo EverFlo, w/Oxygen Percent Indicator, 230V, UltraFill, AUGenerator, oxygen, portable1 death5 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 230V, CNGenerator, oxygen, portable2 deaths4 reports
- EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, IT, CLGenerator, oxygen, portable3 reports
- EverFlo EVERFLO 120V w/O2 Percent Indicator, UltraFill, USGenerator, oxygen, portable3 reports
- EverFlo EVERFLO QUIET w/O2 Percent Indicator, 120V, UltraFill, USGenerator, oxygen, portable3 deaths3 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V, L.AGenerator, oxygen, portable1 death2 reports
- EverFlo EVERFLO w/O2 Percentage Indicator, 220V, LA, BRGenerator, oxygen, portable2 reports
- EverFlo EVERFLO QUIET, NON-O2 Percent Indicator, 120V, US, CAGenerator, oxygen, portable1 death2 reports
- EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, CHGenerator, oxygen, portable2 reports
- EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, ARGenerator, oxygen, portable1 report
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 230V, HKGenerator, oxygen, portable1 report
- EverFlo EVERFLO, 120V, UltraFill, USGenerator, oxygen, portable1 report
Recent EverFlo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Thermal Decomposition of Device
This notification was opened for review due to an allegation of the concentrator shows a burn mark on the housing. There was no allegation of patient harm/injury.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 50869640 ↗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 11, 2026Thermal Decomposition of Device
The manufacturer received information alleging no flow and burning smell. The device settings during the event were reported to be unknown. There was no allegation of serious or permanent harm or injury. No medical intervention was specified by the patient. Preliminary findings found that the clogged sieve caused the compressor to become overloaded and overheat, resulting in a burning smell. During the evaluation, the debug technician also noticed that the manifold was melted. Based on these findings, the sieves need to be replaced. Additionally, the inside of the rear cabinet is damaged, the whisper cap is cracked, and the capacitor is electrically defective. The inlet filter was replaced as part of preventive maintenance. The device was returned unrepaired to the manufacturer's Product Investigation Lab (PIL) for further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725444 ↗MalfunctionSep 7, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657951 ↗MalfunctionSep 2, 2026Thermal Decomposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570115 ↗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 25, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438847 ↗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 ↗InjuryAug 18, 2026Defective Alarm; Failure to Deliver
The manufacturer received information alleging that a patient using an EverFlo oxygen concentrator experienced insufficient oxygen delivery during clinical and therapeutic use. The patient's daughter reported that the patient's peripheral oxygen saturation (SpO2) decreased to 70% for an unspecified period of time, with no device alarm sounding during the alleged event. The patient's condition reportedly deteriorated, resulting in EMS transport to a hospital and subsequent admission.The device underwent an initial inspection by a technical service team, including testing of the pressure delivery system and alarm conditions related to flow and FiO2. The device passed the preliminary testing, and the alarms functioned as intended during simulated low-flow and decreased FiO2 conditions. It was noted that the device had been in use for approximately 5,100 hours over the past 7 months (equivalent to 24 hours per day) and had accumulated a corresponding amount of dust.The manufacturer's investigation is ongoing. A follow-up report will be submitted when the manufacturer's investigation is complete.
Patient problems: Low Oxygen Saturation
MAUDE report 50309251 ↗MalfunctionAug 17, 2026Thermal Decomposition of Device
The device was sent to a third-party service center for investigation. During the evaluation, the third-party service center noted a melted cable. The device will be forwarded to the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation. A follow up report will be sent once the investigation is concluded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268677 ↗MalfunctionAug 13, 2026Thermal Decomposition of Device
The device was sent to a third-party service center for investigation. During the evaluation, the third-party service center found that the unit had a burned capacitor and that the PCA and fuse were also burned. 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 50242684 ↗MalfunctionAug 13, 2026Thermal Decomposition of Device
The device was sent to a third-party service center for investigation. During evaluation, the third-party service center found a burnt PCA. 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 50242680 ↗MalfunctionAug 12, 2026Thermal Decomposition of Device
The manufacturer was contacted in reference to the Everflo device. There was a report of device interior full of white powder. There was no allegation of serious or permanent harm or injury. No medical intervention was specified by the patient. The device was returned to the Third-party service center for evaluation. During the evaluation of the device there was evidence of Front cabinet has external burned, Label warning need to be replaced, Rear Cabinet need to be replaced because is smell a tobacco, Sieve is leakage zeolite, Tube Braided Silicone needs to be replaced, Manifold and OPI Concentrator tubing are out of use is yellowed and fissure and is losing air and contaminated with tobacco, Flowmeter is broken, Inlet Filter need to be replaced for preventive maintenance. The device was requested to be sent to the manufacturer's Product Investigation Lab (PIL) for further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220977 ↗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 ↗MalfunctionAug 6, 2026Thermal Decomposition of Device
This notification was opened for review for information received that the EVERFLO INTL OPI 230V device stating a confirmed complaint due to found device has "thermal damage - power cord burnt" and leak zeolite. The device is pending return and evaluation. If any additional information is received, a follow up report will be filed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160429 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
- Philips DreamStation190 models · 32,422 reports
- Trilogy46 models · 21,644 reports · 11 recalls
- Trilogy Evo20 models · 5,473 reports · 12 recalls
- Trilogy 1008 models · 5,088 reports
- BiPAP System One 60 Series40 models · 4,599 reports
- BiPAP A4037 models · 1,606 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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