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UPDATE: On May 19, 2022, the FDA updated this safety communication to provide the latest information about medical device reports (MDRs) associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls. In addition, the FDA has taken additional actions since this updated safety communication was issued in November 2021. The updates are described in the FAQs: What the FDA is Doing.

The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. This update provides additional information on the recall for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication.

In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) 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 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 and require medical intervention to prevent permanent injury. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer.

If you use one of these recalled devices, follow the recommendations listed below.

Philips recalled the following devices made between 2009 and April 26, 2021:

Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers.

The devices are used to help breathing. Three types of devices have been recalled:

PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users.

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

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

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

During the 2021 manufacturing facility inspection, 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 VOCs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program.

Currently, 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 FDA 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.

Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.

Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam breakdown. Eight of those reports were from the U.S. There were no reports of patient injury or death among those 30 MDRs.

Since April 2021 through April 30, 2022, the FDA received more than 21,000 MDRs, including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.

See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls.

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.

The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls.

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

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