In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Additionally, the foam damage may get worse in hot and humid settings and by using ozone or ultraviolet (UV) light cleaners or other cleaning methods not recommended by the manufacturer. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators with specific serial numbers, also related to the potential health risks posed by the polyester-based polyurethane foam.

In response to the June 2021 recall, in August 2021 the FDA initiated an inspection of a Philips Respironics' manufacturing facility to determine what may have caused or contributed to the foam issues and assess adherence to the agency's quality system regulations. FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality.

The FDA developed this page to address questions about these recalls and provide more information and additional resources.


On this page:

Related FDA pages:


2021 FDA Inspection

The FDA conducted an inspection, completed in November 2021, of a Philips Respironics' manufacturing facility to determine what may have caused or contributed to the foam issues identified in the June 2021 recall of CPAP, BiPAP and certain ventilator devices. During the inspection, the FDA investigator made several observations that are outlined in an inspection closeout report, issued in November 2021, also known as an "FDA Form 483." The FDA investigator provided a list of their observations to the company. An FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. The FDA is carefully evaluating the findings of the inspection, the company's response to the inspectional observations, and the totality of information available to the agency in determining appropriate next steps.


Recall of Certain Trilogy Evo Ventilators

On January 26, 2022, the FDA provided an update related to the recall of certain Philips Respironics ventilators.

In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021 with specific serial numbers. The FDA classified this recall as a Class I recall in January 2022. These devices were not included in the June 2021 recall of Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines.

As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021.

For more information, see the Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam.


Repairing and Replacing the Devices Recalled in June 2021

Following the June 2021 recall, Philips Respironics developed a plan to repair or replace recalled devices. As part of the plan, the company is replacing the polyester-based polyurethane foam with a different, silicone-based foam. The FDA approved this plan based, in part, on testing the company conducted of the new foam. On September 1, 2021, Philips Respironics announced the start of its repair and replacement program for recalled first-generation DreamStation CPAP and BiPAP devices. For details, see Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification.

On October 18, 2021, Philips Respironics reported it "has produced a total of approximately 750,000 repair kits and replacement devices, of which more than 250,000 have reached customers."

During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called Volatile Organic Compounds.

The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.

The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. While this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the agency has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. 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, and the FDA will communicate those results to the public as soon as they are available. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment.

Read the FDA's press release for more information.


How to Tell if Your Device Has Been Recalled and What to Do Next

  1. Read the FDA's recommendations for the type of device you have:
  2. 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 repair.
  3. Watch the short video for an overview of the following steps, including how to tell if your device has been recalled and how to register with Philips Respironics.
  4. Find your device's serial number.
  5. Register your device.
    • Go to Urgent: Field Safety Notification on the Philips Respironics 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.
    • To register by phone or for help with registration, call Philips Respironics at 877-907-7508 (For Spanish translation, press 2; Para español, oprima 2).
  6. Keep your registration confirmation number.
    • After you finish registering, the Philips Respironics website will display your registration confirmation number. It's important to keep your registration confirmation number and serial number where you can easily find it because Philips Respironics will ask for both in future communications. Registering with Philips Respironics will also give them your contact information for future communication.
  7. If you have a health issue, are using or have used a recalled device, 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.

If you do not find your device on the list of Recalled Devices 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.

What the Health Risks Are

Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent injury.

The potential health risks from sound abatement foam are described in the FDA's safety communication.

How to Know if You Should Stop Using Your 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 or repaired 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 impacted device.

Philips Respironics has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website.

What to Do with Your Device: Cleaners, Filters, Foam, Returns

Cleaners: Follow Philips Respironics' instructions and recommended cleaning and replacement guidelines for your device and accessories. Do not use ozone or ultraviolet (UV) light cleaners. Ozone cleaners may break down 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 devices and accessories. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories.

Filters:

  • CPAP and BiPAP devices: Do not add a filter to your CPAP or BiPAP device. A filter may change how the device works and will not help to lessen contact with certain chemicals that may come off the foam.
  • Ventilators: At this time, the FDA is evaluating a filter, but the agency does not have proof of the safety and effectiveness of a filter for lessening the risks from the foam. The FDA's evaluation of the effectiveness of the filter is ongoing, as noted in the FDA's safety communication.

Foam: Do not try to remove the 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 foam or chemicals entering the air tubing of the device.

Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. If you no longer use your recalled device, return it to Philips Respironics by contacting Philips Respironics, your local Philips Respironics representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device.

What Philips Respironics is Required to Do

Philips Respironics is responsible for fixing this issue and creating a recall strategy that includes:

  • Considering the results of the health hazard evaluation to reduce the health risks to people using the recalled devices
  • Identifying the recalled medical devices and notifying affected customers
  • Figuring out the number of devices in use and in distribution
  • Creating a plan to repair or replace recalled devices
  • Repairing and replacing the recalled devices.

Philips Respironics has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips Respironics devices, including the:

  • A-series BiPAP machines
  • DreamStation Go
  • OmniLab Advanced+
  • REMstar SE Auto

In addition, Philips Respironics, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR 820).

What the FDA Is Doing

The FDA is committed to assuring that the devices no longer present a health hazard, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP devices, and addressing concerns and questions from patients and providers. As we continue to work diligently on this recall and develop solutions, we will keep the public informed as more information becomes available.

The FDA is:

  • Assessing the safety and effectiveness of Philips Respironics' actions to fix the products and carry out the plan to repair and replace recalled devices.
  • Monitoring the repair or replacement of impacted devices until Philips Respironics has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation.
  • Evaluating Philips Respironics' plan to repair and replace the Trilogy 100 and 200 ventilators (Note: Garbin Plus, Aeris, LifeVen devices are trade names for Trilogy 200).
  • Tracking Philips Respironics' strategy to replace certain Trilogy Evo ventilators with specific serial numbers, which were recalled in December 2021.
  • Overseeing Philips Respironics' replacement of C-series BiPAP machines, E30, and SystemOne (ASV4 and Q-series) devices with another replacement device.
  • Receiving and reviewing medical device reports (MDRs) related to the foam issue.
  • Encouraging Philips Respironics to have a consistent and transparent approach for repairing or replacing the impacted devices with safe and effective devices.
  • Working with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall.
  • Partnering with stakeholders to distribute a voluntary survey to better understand patient experiences related to specific recalled medical devices. The survey informs the FDA's work overseeing the effectiveness of the recall.
  • Working with other manufacturers and government partners to try to help make available more CPAP and BiPAP devices.

The FDA has:

In general, when the FDA finds out about a company's recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page.

How to Report a Health Issue or Problem with Your Device

If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.

Questions?

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

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