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URGENT: Philips Respironics Recently Issued a Recall Notice for Certain Sleep and Respiratory Care Devices

One Jun 14, 2021, Philips Respironics issued a recall notice in the U.S. for certain Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices. The cause of the recall is potential health risk associated with the polyester-based polyurethane (PE-PUR) sound abatement foam component used in these devices. The foam may degrade into particles that can be inhaled by the user, potentially resulting in future harm.

What You Should Do if You Use a Philips BiLevel PAP or CPAP Device:

  1. Determine if your device is affected by the recall by visiting the manufacturer’s Recalled Device Registration Page and checking to see if your machine is included on the list of affected models. On this page, you can register your recalled unit and initiate the process to obtain a safe replacement material for the sound abatement foam in your machine. Note: replacement make take up to one year for some units.
  2. Discontinue use of your affected machine and consult with your physician to determine the benefits of continuing therapy and any potential risks.
  3. Cease the use of ozone cleaners/sanitizers for cleaning PAP and CPAP machines. Patients should clean their PAP and CPAP devices only according to manufacturer recommendations.

For More Information About the Philips Recall:

  • Visit Philips’s Device Registration Page for this recall
  • Or call Philips for any manufacturer-related questions at 877-907-7508
  • Or call the UH Hotline at 216-358-1577 (Monday – Friday: 8:30 a.m. – 5 p.m.)
  • For sleep centers, sleep medicine professionals and other providers: view the AASM guidance in response to the Philips recall of PAP and CPAP devices.