For nearly a year, millions of Americans who use CPAP devices to treat sleep apnea have been left up in the air due to a massive recall by Philips Respironics. The medical device manufacturing company began a voluntary recall of CPAP, BiPAP, and ventilator devices in June of 2021. However, because of the scale of the recall, millions of people have not yet been able to receive replacement devices, and many have been forced to choose between going without treatment or potentially putting themselves at risk of harm through the use of devices that may be unsafe. Multiple agencies in the United States government have been looking into the recall, and they may take action against Philips to address the ways consumers have been affected.

Actions Taken Against Philips by the FDA and DOJ

Philips began its recall of CPAP machines and similar devices because it learned that the products contained a dangerous substance that could break down over time. A polyester-polyurethane foam had been used in these devices to dampen sound and help them operate more quietly. Unfortunately, the breakdown of this foam may have led users of the devices to inhale tiny particles and toxic chemicals, leading to potential lung injuries and other health issues.

While Philips announced the recall in June 2021, company records indicate that it knew about the potential health hazards for months or years and failed to take action. After announcing the recall, the company has struggled to ensure that consumers and medical device suppliers are informed about the issue, and many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) has been overseeing the recall, and it recently issued an order requiring Philips to create more effective notification procedures.

Since June of 2021, Philips Respironics, a Dutch medical device manufacturer, has been undertaking a massive recall of CPAP devices and other types of ventilators. This recall was initiated because the devices used a sound abatement foam that could potentially cause harm to users. When this foam breaks down over time, “black debris” consisting of foam particles may be inhaled by those using the devices, and volatile organic compounds or other dangerous chemicals may also be released. Users of the devices may be at risk of lung injuries and other serious illnesses. 

The CPAP recall involves around 2.6 million devices in the United States and 5.2 million devices worldwide. While Philips has made efforts to notify users about the recall, many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) recently issued a notification stating that the company’s efforts to ensure that people are properly informed about the recall have been lacking, and it is requiring Philips to take certain actions to comply with its requirements.

FDA Requirements Addressing Inadequate Notification Procedures

To determine whether the actions taken by Philips to notify people about the recall have been effective, the FDA contacted 182 suppliers of CPAP devices and other medical equipment. It found that 28 of these suppliers were not aware of the recall, meaning that their customers were also most likely unaware of the potential risks that may affect them when they use these devices.

Many people throughout the United States who rely on CPAP machines to treat sleep apnea have had their lives disrupted by a major recall of these devices. In 2021, Philips Respironics recalled millions of these products, including Dreamstation CPAPs and other CPAP, BiPAP, and ventilator devices. The recalled devices contained a polyester/polyurethane foam that has been found to degrade throughout the months and years of daily use, potentially exposing people to toxic substances that could cause serious health issues. 

People who use devices that have been recalled may be wondering about their options. Since sleep apnea can be a serious issue that may affect a person’s overall health, stopping treatment could lead to a variety of problems. However, because there are millions of defective devices, replacements may not be available for some time. Philips is working to provide replacements, and the company expects this process to take a year or more. Other CPAP manufacturers are also struggling to meet demands and provide people with products that can offer the treatment they need. As CPAP users work to determine their options, they will want to understand the advice that doctors may give about how they can receive effective treatment for sleep apnea.

Treatment Options That May Be Recommended by Doctors

Since every person’s case is unique, there is no single correct answer for what a person should do if they are using a CPAP device that has been recalled. People should consult with their doctor to determine the approach they should take. Doctors may advise patients to take a number of different actions, including:

Philips Respironics, a medical device manufacturer, has released multiple different types of products used to provide breathing assistance or sleep apnea treatment, and these devices are used by medical facilities or in people’s homes. In June of 2021, the company initiated a massive recall of multiple types of devices, including CPAP and BiPAP machines and ventilators. This recall was done because the devices contained a polyester/polyurethane foam that has been found to degrade over time. When the foam breaks down, particles of the foam could be inhaled by a patient, and toxic chemicals may also be released that could endanger a person’s health. Recently, Philips recalled some additional ventilator devices for the same reason.

Recall of Trilogy Evo Ventilators

On December 12, 2021, Philips notified customers using its Trilogy Evo ventilators that the devices were being recalled, and the company sent an update on January 13, 2022 to provide additional safety information. These devices, which were not included in the June 2021 recall, had used the same foam as the other recalled devices. They were manufactured and distributed to customers in April and May of 2021.

Because the recalled ventilators may be used by patients to provide essential breathing support, it may not be feasible to stop using a device until a replacement can be obtained. This means that some patients may need to continue using these devices and putting themselves at risk. The recall notice stated that patients or caregivers should monitor a device’s bacteria filter and look for foam debris. The use of an additional in-line bacteria filter may also help prevent the inhalation of foam particles.

Millions of people have been affected by the recall of CPAP and BiPAP machines performed by Philips Respironics in 2021. These devices were recalled because of a foam that was used in the machines for noise-dampening purposes. The degradation of the foam, which could occur throughout the life of a device, could potentially lead to small foam particles and toxic chemicals being inhaled by users while they were receiving treatment for sleep apnea. One issue that was raised by Philips in its recall notice was the use of certain types of cleaning devices that purified CPAP parts through the use of ozone. CPAP users who also used ozone cleaners will want to understand how this may have affected their health and safety.

Manufacturer of Ozone Cleaners Sues Philips Respironics

When it issued its notice recalling multiple different types of CPAP and BiPAP devices, as well as medical ventilators, Philips stated that the use of unapproved cleaning methods, including cleaning devices that use ozone, may have exacerbated the degradation of the foam in the devices, increasing the likelihood that users could be exposed to harmful particles and chemicals. In October of 2021, SoClean Inc, a manufacturer of ozone cleaners, filed a lawsuit against Philips, claiming that the company had made false and misleading claims about the causes of foam degradation. The lawsuit stated that SoClean’s sales have fallen and its brand’s reputation has suffered as a result of the statements made by Philips. It also stated that Philips is attempting to divert blame for injuries suffered by CPAP users, when the true reasons for these issues are design flaws and a poor choice of materials. SoClean believes that the use of ozone when cleaning CPAP machines does not lead to the breakdown of foam, but degradation is actually caused by high humidity and contact with water.

Ozone CPAP Cleaners Not Approved by FDA

While it is still unclear whether the use of ozone cleaning devices is a factor in the degradation of foam in CPAP devices, it should be noted that these types of cleaners have not been approved by the FDA. Instead, the FDA recommends that users follow the manufacturer’s cleaning instructions, which usually state that CPAP devices and parts should be cleaned with soap and water.