Recommendations for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

Update: April 2024

On April 9, 2024, a federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to prioritize patient relief and ensure the company's regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure (BiPAP) machines in June 2021 because of potential health risks—impacting 15 million devices worldwide. Patients impacted by the Philips recall remain a top priority for the agency as the FDA continues to take steps to protect the health and safety of individuals using these devices.

The consent decree includes provisions:

• Requiring implementation of a Recall Remediation Plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall by way of receiving a new or reworked/remediated device, or for certain devices, providing the option for a partial refund.
• Restricting, with limited exceptions, the production and sale of new CPAP machines, BiPAP machines, and other devices at several Philips Respironics facilities in Pennsylvania and California until certain requirements are met.

For more information, see the FDA's press release.

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On this page:

• How Do I Know If My Device Was Recalled?
• What Should I Do If My Device Was Recalled?
• What Are the Health Risks from Using a Recalled Device?
• Should I Stop Using My Recalled Device?
• What are the Recommendations for Recalled Ventilators?
• What are the Recommendations for Recalled BiPAP or CPAP Machines? 
• What are the Recommendations for Repaired and Replaced BiPAP or CPAP Machines?
• Can I Use Cleaners and Filters with My Recalled Device?
• How Do I Report a Problem to the FDA?
• Who Can I Contact if I Have More Questions?

Related FDA pages

• Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
• FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
• Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
• Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

In June 2021, Philips Respironics (Philips) recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines because of potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious injury and may require medical intervention to prevent permanent injury.

The FDA recognizes that many patients have questions about what this information means for the status of their devices. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, COPD (chronic obstructive pulmonary disease) Foundation, Muscular Dystrophy Association, Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and American Academy of Sleep Medicine. The FDA has included this feedback on this page.

How Do I Know If My Device Was Recalled?

• Watch the short video from Philips for an overview of how to tell if your device has been recalled, how to register with Philips, and what to expect after registration.
• You can also find more information about the recalled devices in the FDA's Medical Device Recall Database.

What Should I Do If My Device Was Recalled?

1. Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repaired device.
2. Read the FDA's recommendations for using the following types of devices:
   • Recalled Ventilators
   • Recalled BiPAP or CPAP Machines
   • Repaired and Replaced BiPAP or CPAP Machines
3. Find your device's serial number. 
   • See How to Locate the Serial Number on your device on the Philips website. 
   • If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier [commonly known as a Durable Medical Equipment (DME) supplier] who gave you your device. The DME supplier can check to see if your device has been recalled.
4. Register your device.
   • Go to Urgent: Field Safety Notification on the Philips website and begin the registration at the bottom of the page (Iniciar proceso de registro para espanol). After you enter your device's serial number during registration, the site will tell you if it is one of the recalled models.
   • If you want to be considered for prioritized replacement, include the additional requested information when you register your device. If you already registered your device, you may update your existing registration on the Philips patient portal. You may visit the online patient portal and update your information even if you did not receive an email notification from Philips. If you do not provide the additional requested information, you will receive a replacement device based on when you registered.
   • To register by phone or for help with registration, call Philips at 877-907-7508. For Spanish translation, press 2; Para español, oprima 2.
5. Keep your registration confirmation number. 
   • After you finish registering, the Philips website will display your registration confirmation number. 
   • It is important to keep your registration confirmation number and serial number where you can easily find them because Philips will ask for both in future communications. Registering your device will also give Philips your contact information for future communications.
6. Check the status on the Philips' patient portal.
   • Registered consumers will receive a required notification from Philips, in accordance with the Recall Remediation Plan required to be implemented under the consent decree, about options, including a repaired device, a replaced device, or in some cases the option for a partial refund, as well as next steps to take.
7. Report problems to the FDA. If you have a health issue or have any problem with your device, talk to your health care provider and report the problem through the FDA's MedWatch Voluntary Reporting Form.

What Are the Health Risks from Using a Recalled Device?

The PE-PUR foam is used to lessen sound and vibration in ventilators, BiPAP machines, CPAP machines, and other medical equipment. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. In June 2021, the FDA alerted people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks. The alert was based on problems reportedly associated with the PE-PUR foam breakdown that could potentially result in serious injury and may require medical intervention to prevent permanent injury.

When the PE-PUR foam breaks down, it may:

• Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the person using the device. You may or may not see black pieces of the foam in the air tubes or masks.
• Release certain chemicals, such as volatile organic compounds (VOCs), into the device's air tubes and be inhaled by the person using the device or others near the device. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. In addition, using cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown.

The potential risks of inhaling or swallowing pieces of PE-PUR foam include:

• Irritation to the skin, eyes, nose, and respiratory tract (airway)
• Inflammatory response
• Headache
• Asthma
• Toxic or cancer-causing effects

The potential risks of inhaling certain chemicals released into the device's air tubes from the PE-PUR foam include:

• Headache
• Dizziness
• Irritation in the eyes, nose, respiratory tract (airway), and skin
• Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
• Nausea or vomiting
• Toxic and cancer-causing effects

Should I Stop Using My Recalled Device?

To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor.

For some patients, stopping use of the recalled device may involve greater risk than continuing its use. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled device.

Philips has agreed to conduct additional testing and submit information related to the risks related to the PE-PUR foam, and we will continue to review that information as it is received.

What are the Recommendations for Recalled Ventilators?

Recommendations for People Who Use Recalled Ventilators at Home and Their Caregivers

• Do not stop or change ventilator use until you have talked to your health care provider.
• Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. The FDA's evaluation of the information provided by Philips is ongoing. It is important to note the following considerations:
  • Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam.
  • Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately.
  • If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems.
• Register your device(s) on Philips' recall website or call 1-877-907-7508 to provide additional information to help prioritize replacement of your device and to get updated information from Philips. For Spanish translation, press 2; Para español, oprima 2.
• If you have a health issue or any problem with your device, talk to your health care provider and report the issue or problem through the MedWatch Voluntary Reporting Form.

In addition to the updated safety communication issued on November 12, 2021, the FDA issued another safety communication on December 22, 2022, to provide additional information to patients, caregivers, and health care providers about two more issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. Those Philips Trilogy 100 and Trilogy 200 ventilators were a part of the recall in June 2021 for issues with the PE-PUR sound abatement foam breakdown. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Additionally, Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris.

Recommendations for Health Care Providers and Facilities

• Follow the recommendations above for the recalled devices used in health care settings.
• Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device.
• If you treat a patient who has a health issue or have any problem with a device, report the issue or problem through the MedWatch Voluntary Reporting Form.

What are the Recommendations for Recalled BiPAP or CPAP Machines? 

• Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Your provider may advise you to:
  • Stop using your recalled device. (See Should I Stop Using My Recalled Device?)
  • Use another similar device that is not a part of this recall.
  • Continue to use your recalled device, if you and your health care provider decide that the benefits of using it outweigh the potential health risks.
  • Use other treatments for sleep apnea, such as:
    • Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back.
    • Oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
    • Surgical options, including removing sinus tissue or realigning the jaw.
  • Make lifestyle changes, such as:
    • Lose weight
    • Avoid alcohol
    • Stop smoking
• Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Do not use ozone or ultraviolet (UV) light cleaners. Ozone cleaners may worsen the breakdown of the PE-PUR foam, even if you do not see the pieces of foam in the air tubes, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.
• Register your device(s) on Philips' recall website. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing registration on the Philips' online patient portal and provide additional information. You may visit the online patient portal and update your information even if you did not receive an email notification from Philips. If you do not provide the additional requested information, you will receive a replacement device based on when you registered. You may also check the status of your replacement device on Philips' online patient portal or by calling 1-877-907-7508. For Spanish translation, press 2; Para español, oprima 2.
• Do not use an additional filter with a CPAP or BiPAP machine.
• Do not try to remove the PE-PUR foam from your device. Trying to or successfully removing the foam may damage the device or change how the device works. It may also lead to more PE-PUR foam or chemicals entering the air tubing of the device.
• If you have a health issue or any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.

What are the Recommendations for Repaired and Replaced BiPAP or CPAP Machines?

• Be aware that during an inspection of a Philips' manufacturing facility in Murrysville, PA, between August-November 2021, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs).
  • Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results.
  • The FDA requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
• Continue to use your repaired or replaced device.
  • If you have additional concerns, talk to your health care provider about the plan for your care and treatment.
  • The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients.

Can I Use Cleaners and Filters with My Recalled Device?

Cleaners

Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Do not use ozone or ultraviolet (UV) light cleaners. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories.

Filters

• Ventilators: At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. The FDA's evaluation of the information provided by Philips is ongoing, as noted in the FDA's safety communication (Archived).
• BiPAP and CPAP machines: Do not add a filter to your CPAP or BiPAP machine. A filter may change how the device works and will not help to lessen contact with certain chemicals that may come off the foam.

How Do I Report a Problem to the FDA?

If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Who Can I Contact if I Have More Questions?

For more information on Philips' recall notification, contact your local Philips representative or visit Philips' medical device recall information page.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

If you have additional questions, contact the FDA's Division of Industry and Consumer Education (DICE).