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Notice: Patient recommendations regarding Philips Respironics device recall

On June 14, 2021, WellSpan Health was notified by Philips Respironics of their voluntary recall for certain CPAP, BiLevel PAP devices (sleep apnea machines) and mechanical ventilators due to issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices.

For information on the Philips Respironics device recall notice, a complete list of impacted products, potential health risks, further information, or to register your device to check if it is affected, please visit: philips.com/src-update.

We urge all patients with an affected Philips Respironics device to register the device as soon as possible directly with Philips Respironics. If your device is part of the recall, you will be prompted to fill out an additional information form to start the recall process.

You may also call Philips Respironics directly at 877-907-7508, Monday-Friday 8 a.m. to 8 p.m. EST.

Philips also advises users to avoid using ozone products to clean your PAP device and avoid using your device in areas of excessive heat and humidity. Philips reports that ozone-related cleaners may help wear down the foam in the device. Clean your device with soap and water only.

For many patients, the consequences of discontinuing CPAP or BiPAP use may be worse than the potential consequences which have led to the recall. Patients should discuss the decision to continue use of the recalled device with a provider.

If a patient’s recalled device is a life-sustaining mechanical ventilator:

  • DO NOT stop using the device.
  • Please talk to your provider to discuss potential treatment options.

If your recalled device is a CPAP or BPAP device for sleep apnea:

  • The FDA advises you to talk to a health care provider to decide on a suitable treatment for your condition. Please talk to your provider to discuss potential treatment options.

Based on new guidance from Philips Respironics, WellSpan does not recommend the use of inline bacterial filters with a CPAP or BiPAP device.  Philips recently posted new guidance related to use of bacteria filters on their website. The information very clearly discourages the use of any bacteria filters with the recalled CPAP and BiPAP devices. Based upon this new information, with the safety of our patients in mind, WellSpan no longer offers bacteria filters for use with the recalled Philips devices.