OmniLab Advanced PlusRecalls & reported problems across all models
Respironics, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one OmniLab Advanced Plus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 5 models of OmniLab Advanced Plus by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2022 and Jul 6, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (7 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
OmniLab Advanced Plus recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 26, 2022Class IOpen, Classified
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1658-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Aug 26, 2022Class IOpen, Classified
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1657-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported OmniLab Advanced Plus problems
Device problems
- Electrical /Electronic Property Problem7
- Degraded4
- Unexpected Shutdown2
- Increase in Pressure1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Cough1
OmniLab Advanced Plus models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OmniLab Advanced Plus OmniLab Advanced Plus, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 recalls8 reports
- OmniLab Advanced Plus OmniLab Advanced Plus, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall3 reports
- OmniLab Advanced Plus OmniLab Advanced Plus with Heated Tube Humidifier, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 reports
- OmniLab Advanced Plus OmniLab Advanced Plus with Heated Tube Humidifier, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
- OmniLab Advanced Plus OmniLab Advanced Plus with Humidifier, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
Recent OmniLab Advanced Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT, DURING A CPAP TITRATION STUDY, THE OMNILAB ADVANCED PLUS FLOW GENERATOR (DOM) GENERATED ALARMS AND DISPLAYED AN INOPERATIVE MESSAGE WHILE IN PATIENT USE. THE REPORTED ISSUE HAS BEEN IDENTIFIED UNDER FSN 2023-CC-SRC-039 AND IS ASSOCIATED WITH INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THE REPORTER INDICATED THAT, AFTER SEVERAL RESTART ATTEMPTS, THE DEVICE RESUMED OPERATION WITHOUT FURTHER ALARMING. THE THERAPY PRESSURE WAS OBSERVED TO HAVE CHANGED FROM 6 CMH2O TO 10 CMH2O. THE CALLER REQUESTED GUIDANCE REGARDING CONTINUED USE AND WAS ADVISED THAT THE DEVICE SHOULD NOT BE USED UNTIL IT HAD BEEN ASSESSED AND VERIFIED WITH A MANOMETER. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF THE DEVICE IS RETURNED FOR EVALUATION OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THE MANUFACTURER WILL INVESTIGATE THE EVENT AND SUBMIT A FOLLOW-UP REPORT, AS APPROPRIATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25719594 ↗MalfunctionFeb 17, 2026Degraded
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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369127 ↗MalfunctionAug 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923103 ↗MalfunctionAug 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923024 ↗MalfunctionMar 20, 2024Increase in Pressure; Increase in Pressure
THE MANUFACTURER RECEIVED INFORMATION REGARDING AN OMNILAN ADVANCED PLUS. THE CUSTOMER ALLEGES THE DEVICE SEEMED TO BLOW HARDER THAN THE SETTING THE DEVICE WAS PLACED ON WHEN THE PATIENT BEGAN USE OF THE DEVICE. THE CUSTOMER ADJUSTED THE PRESSURE, THEN THE DEVICE ALARMED AND DISPLAYED A VENT INOPERABLE MESSAGE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941747 ↗MalfunctionMar 8, 2024Unexpected Shutdown; Unexpected Shutdown
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. 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 18866500 ↗MalfunctionFeb 29, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE DEVICES PCA AND BOTTOM ENCLOSURE WERE REPLACED AND THE FIRMWARE UPDATED TO V3.7. THE DEVICE PASSES TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18810999 ↗MalfunctionFeb 28, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MAIN PCA AND BLOWER ASSEMBLY WERE REPLACED TO RESOLVE THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797604 ↗MalfunctionFeb 27, 2024Power Problem; Power Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CHECK AC POWER SUPPLY ERROR OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. PER THE CUSTOMER THEY TRIED A DIFFERENT OUTLET AFTER IT HAS ALARMED AND IT WORKED FINE. THE DEVICE DID HAVE ECG SPIKES, THE IMPEDANCE VALUES WERE RED AND COULD HAVE BEEN THE CAUSE FOR THE SPIKES IN THE HEART RATE CAUSING THE HIGH VALUES. THE BODY POSITION SENSOR WAS ALSO CAUSING INCORRECT READINGS. THE CUSTOMER INDICATED THAT THEY DID NOT SEE SENSORS ON THE BELTS. THEY WILL CHECK WITH OUTSIDE SALES TO SEE IF THEY WERE PROVIDED TO THEM. IF THEY HAVE FURTHER PROBLEMS THEY WILL CALL BACK. NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794169 ↗MalfunctionFeb 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER INFORMED THE TECH THAT THE DEVICE WAS ON A PATIENT WHEN THE VENT INOPERATIVE ALARMED. THEY RESTARTED THE DEVICE AND IT WORKED FINE AFTER THAT. THE TECH INFORMED THE CUSTOMER THE DEVICE WILL NEED SERVICED. PROVIDED THE NOTIFICATION NUMBER AND TRANSFERRED THE CUSTOMER TO REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793927 ↗MalfunctionFeb 27, 2024Unexpected Shutdown; Unexpected Shutdown
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE TURNS OFF. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER THEY WERE NOT ABLE TO CONFIRM CUSTOMERS COMPLAINT. THE DEVICE RAN OKAY AND PASSED THE TEST STAND. NO ERRORS FOUND IN ERROR LOG INDICATING FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793926 ↗MalfunctionFeb 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER INFORMED THE TECH THAT THE DEVICE WAS TURNED OFF AND THEN ON AGAIN AND THE ISSUE WENT AWAY. CUSTOMER WAS SENT THE NEWEST SOFTWARE VERSION FOR THE DEVICE. THE CUSTOMER INDICATED THEY WOULD GET THAT UPLOADED AND IF THEY HAVE ANY FURTHER ISSUE THEY WOULD CALL BACK. NO FURTHER ACTION WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793924 ↗MalfunctionDec 29, 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 TO COUGH. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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: Cough
MAUDE report 16068817 ↗MalfunctionMar 31, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13961713 ↗MalfunctionMar 23, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND NOISY BLOWER; BOTTOM ENCLOSURE, RIGHT SIDE ASSY, TOP ENCLOSURE DAMAGED BY UNKNOWN LIQUID AND DAMAGED INLET FOAM WERE OBSERVED DURING DEVICE EVALUATION. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869774 ↗
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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