REMstar REMstar Heated HumidifierRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00606959046375), received between Mar 14, 2018 and Oct 16, 2024 — classified as 2 deaths, 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Degraded” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT IS ALLEGING LUNG DISEASE, NAUSEA, VOMITING, INFLAMMATORY RESPONSE. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED. 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: Inflammation; Nausea; Unspecified Respiratory Problem; Vomiting

  MAUDE report 20462477 ↗
• DeathJun 23, 2024Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED ABOUT A VOLUNTARY FIELD SAFETY NOTICE/RECALL RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED REPORTS ALLEGING THAT THE PATIENT EXPERIENCED DIZZINESS AND/OR HEADACHE AND NONDESCRIPTIVE CANCER; THE MANUFACTURER WAS NOTIFIED THAT THE PATIENT PASSED AWAY. NO SPECIFIC MEDICAL INTERVENTION WAS MENTIONED. THE MANUFACTURER WAS MADE AWARE OF THIS INFORMATION THROUGH THE CUSTOMER¿S LEGAL REPRESENTATIVE. DUE TO POTENTIAL LEGAL ISSUES SURROUNDING THIS CASE, NO FURTHER INVESTIGATION OR FOLLOW-UP CAN BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Cancer; Dizziness; Headache

  MAUDE report 19591693 ↗
• InjuryJun 20, 2024Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED ABOUT A VOLUNTARY FIELD SAFETY NOTICE/RECALL RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED REPORTS ALLEGING THAT THE PATIENT EXPERIENCED EYE IRRITATION, NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, ASTHMA - NEW OR WORSENING, INFLAMMATORY RESPONSE, UNSPECIFIED LUNG DISEASE, EMPHYSEMA, AND A NONDESCRIPT ALLEGATION OF "OTHER." NO SPECIFIC MEDICAL INTERVENTION WAS MENTIONED. THE MANUFACTURER WAS MADE AWARE OF THIS INFORMATION THROUGH THE CUSTOMER¿S LEGAL REPRESENTATIVE. DUE TO POTENTIAL LEGAL ISSUES SURROUNDING THIS CASE, NO FURTHER INVESTIGATION OR FOLLOW-UP CAN BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Asthma; Dizziness; Eye Irritation; Headache; Inflammation; Pulmonary Emphysema; Unspecified Respiratory Problem

  MAUDE report 19574123 ↗
• InjuryJun 4, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP/ BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING RESPIRATORY TRACT IRRITATION,DIZZINESS,ASTHMA. NO OTHER CLINICAL INFORMATION OR MEDICAL 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: Asthma; Dizziness; Unspecified Respiratory Problem

  MAUDE report 19463058 ↗
• MalfunctionApr 7, 2024Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A HEATED HUMIDIFIER ALLEGING NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND OR HEADACHE, NAUSEA, VOMITING, INFLAMMATORY RESPONSE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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; Nausea; Skin Inflammation/ Irritation; Vomiting

  MAUDE report 19056869 ↗
• InjuryMar 5, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT ALLEGES NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY AND NAUSEA/VOMITING, ASTHMA (NEW OR WORSENING), INFLAMMATORY RESPONSE AND KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY, LUNG DISEASE AND REDUCED CARDIOPULMONARY RESERVE. 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; Nausea; Skin Inflammation/ Irritation; Unspecified Hepatic or Biliary Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 18838233 ↗
• DeathMar 5, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING RESPIRATORY TRACT IRRITATION, CANCER, AND DEATH. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer; Respiratory Tract Infection

  MAUDE report 18837051 ↗
• MalfunctionJan 25, 2024Degraded; Device Emits Odor; Degraded; Device Emits Odor

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS BURNING PLASTIC TYPE OF SMELL, AND THE VISUALIZATION OF PARTICLES IN TUBING / CHAMBER AND PARTICLES IN AIRWAY FROM THE DEVICE. THE PATIENT ALLEGES LOSING AIR PRESSURE IN THE DEVICE CAUSING DIFFICULTY BREATHING, NASAL IRRITATION AND BLOODY NOSE, COUGHING, AND A LOT OF MUCUS. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THREE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Cough; Dyspnea; Epistaxis; Unspecified Respiratory Problem

  MAUDE report 18578397 ↗
• MalfunctionJan 2, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THE PATIENT ALLEGES EYE IRRITATION, NOSE IRRITATION, DIZZINESS AND/OR HEADACHE, ASTHMA . 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: Asthma; Dizziness; Eye Irritation; Headache

  MAUDE report 18424007 ↗
• MalfunctionNov 8, 2022Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 15752518 ↗
• MalfunctionJul 20, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED PARTICLES IN TUBING/CHAMBER IN THE DEVICE. THE PATIENT ALLEGED NASAL/THROAT IRRITATION OR SORENESS. THERE WAS NO REPORT OF SERIUOS OR PERMANENT PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Respiratory Tract Infection; Sore Throat

  MAUDE report 15068305 ↗
• InjuryMar 14, 2018Improper or Incorrect Procedure or Method; Device Emits Odor; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  AN END USER ALLEGES THAT HE DEVELOPED CARCINOMA OF THE THROAT DUE TO BREATHING WHAT HE DESCRIBED AS A FOUL ODOR FROM HIS HEATED HUMIDIFIER WHEN IT RAN OUT OF WATER DURING AN UNKNOWN AMOUNT OF NIGHTS. THE HEATED HUMIDIFIER WAS IN USE WITH A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE. THE MODEL AND SERIAL NUMBER OF THE CPAP ARE UNKNOWN AT THIS TIME. THE USER STATED HE WAS UNAWARE THAT HIS HUMIDIFIER SETTINGS HAD CHANGED "SOMEHOW" IN DECEMBER, 2015, BUT WAS AWARE THAT THERE WAS NO WATER LEFT IN HIS HUMIDIFIER CHAMBER AT THE END OF HIS THERAPY SESSIONS EACH NIGHT. THE USER WAS DIAGNOSED WITH CARCINOMA LATER (EXACT DATE OF DIAGNOSIS IS UNKNOWN), AND ATTRIBUTES THE DIAGNOSIS TO THE ODOR COMING FROM HIS HUMIDIFIER. THE USER STATED HE CLEANED THE HUMIDIFIER AND CHAMBER, CORRECTED THE HUMIDITY SETTING, AND HAS CONTINUED TO USE BOTH THE HUMIDIFIER AND CPAP. THE USER STATED THAT ALTHOUGH THERE WAS NO MALFUNCTION OF THE DEVICES IN USE AT THE TIME, HE FEELS THE MANUFACTURER SHOULD HAVE SOME SORT OF WARNING FOR THE USERS IF THEY RUN OUT OF WATER IN THE HUMIDIFIER DURING THE NIGHT. THE MANUFACTURER HAS REQUESTED RETURN OF ALL DEVICES IN USE AT THE TIME OF THE ALLEGED EVENT. THE INVESTIGATI

  Patient problems: Cancer

  MAUDE report 7338334 ↗