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The cpap recall by Philips Respironics has affected over 15 million devices worldwide, making it one of the largest medical device recalls in history. If you use a CPAP, BiPAP, or ventilator for sleep apnea, here is what you need to know.
Key Facts About the Philips CPAP Recall:
The recall stems from the sound-dampening foam inside these devices degrading, which can release black particles and toxic chemicals that users may inhale or swallow.
The FDA has received over 100,000 reports of device malfunctions and injuries, with 385 deaths potentially linked to the faulty devices. This is a serious public health crisis affecting millions who depend on these machines for life-sustaining therapy.
I'm Tim Burd, founder of Justice Hero. We help people steer complex medical device recalls and connect with qualified legal representation. Through our work on the cpap recall, we've seen the crisis's impact on families and the importance of understanding your rights.
At the core of the Philips cpap recall is polyester-based polyurethane (PE-PUR) foam, used in its devices to reduce noise and vibrations. Over time, this foam was found to degrade in two primary ways:
Research suggests that high heat, high humidity, and unapproved cleaning methods—particularly ozone cleaners—accelerated this degradation. Philips noted that devices cleaned with ozone were 14 times more likely to degrade, highlighting the importance of following manufacturer-recommended cleaning instructions.
While Philips reported a low complaint rate before the recall, its internal testing later revealed that the PE-PUR foam's degradation products are toxic and potentially carcinogenic. According to investigations by ProPublica and the Pittsburg Post-Gazette, Philips allegedly withheld this information for over a decade before announcing the recall.
The cpap recall initiated by Philips in June 2021 is comprehensive, impacting millions of devices manufactured between 2009 and April 26, 2021. The list of affected devices is extensive and includes popular models:
It's crucial for users to verify if their specific device is part of this recall. We strongly advise you to check the full list of affected devices on the Philips website.
Check the full list of affected devices on the Philips website
The potential health risks stem from inhaling or swallowing the degraded PE-PUR foam particles and chemicals. The FDA and medical bodies have outlined a range of potential health consequences:
Immediate and Short-Term Risks: These include respiratory irritation (cough, chest pressure), headaches, dizziness, inflammatory responses, sinus infections, allergic reactions, asthma, and nausea/vomiting.
Long-Term and Serious Risks: The most alarming concern is the carcinogenic risk from the released chemicals. The FDA has stated the devices can cause permanent injury and serious illnesses. Lawsuits have linked the foam to various cancers, including bladder, brain, breast, kidney, liver, lung, and prostate cancer, as well as potential damage to organs like the kidneys and liver.
The severity of health effects depends on the extent of foam degradation, duration of use, and an individual's health. If you've used a recalled device and experience any of these symptoms, consult your healthcare provider immediately.
For more in-depth information on the potential cancer risks associated with these devices, we encourage you to visit our dedicated page:
Following the June 2021 Philips cpap recall, the U.S. Food and Drug Administration (FDA) took immediate action, classifying it as a Class I recall. This is the most serious classification, indicating a reasonable probability that using the devices could cause serious health problems or death.
The FDA has since received over 100,000 medical device reports (MDRs) detailing malfunctions, injuries, and deaths linked to the recalled devices. The agency also conducted inspections of Philips' manufacturing facilities, uncovering serious quality control issues that may have contributed to the crisis.
Throughout this process, the FDA has issued numerous safety communications and warning letters to keep the public and healthcare providers informed, including alerts about new safety concerns with some replacement devices.
Philips launched a remediation program to repair or replace millions of faulty devices, swapping the PE-PUR foam with new silicone foam replacements. According to Philips, they have remediated over 99% of actionable sleep therapy device registrations globally.
However, the process has been fraught with problems. Global supply chain issues caused significant delays, leaving many patients waiting months for safe machines. More concerningly, some replacement devices have developed new safety issues. The FDA received hundreds of reports of DreamStation 2 overheating issues, including incidents of smoke, fire, and burns, which are still under investigation.
While the new silicone foam is intended to be safer, the FDA has stated it lacks sufficient independent data to fully assess its long-term health risks. Despite these concerns, the FDA generally recommends patients use the replacement devices, weighing the known risks of untreated sleep apnea against the potential risks of the new foam.
Read the latest FDA safety communication
The legal and financial fallout from the cpap recall has been massive. In April 2024, a federal court entered a consent decree against Philips Respironics. This agreement with the U.S. Department of Justice (DOJ) places Philips under strict government oversight, halting U.S. sales of new CPAP and BiPAP machines from certain facilities until they meet specific quality control requirements.
The financial settlements have been staggering. Philips agreed to a $1.1 billion personal injury settlement to resolve lawsuits from individuals harmed by the devices and to fund medical monitoring. This followed a $479 million economic loss settlement in September 2023 to compensate patients for the cost of their recalled devices and out-of-pocket replacement expenses.
These actions came after a ProPublica and Pittsburgh Post-Gazette investigation revealed Philips may have known about the foam degradation for over a decade before the recall. While Philips has not admitted fault, the size of the financial consequences underscores the severity of the situation.
Find out if you are eligible for a CPAP Lawsuit
Navigating the cpap recall can be overwhelming. It's critical to balance the risks of using a recalled device against the dangers of untreated sleep apnea. This is a decision that should be made in consultation with a healthcare professional.
If you use a recalled Philips device, take immediate action. Your first and most important step is to consult your physician.
If you believe you have a case, we can help you understand your options.
As a healthcare provider, your patients are relying on you for guidance during this cpap recall crisis.
The AASM has published excellent resources to help clinicians steer this recall.
Review the AASM guidance for clinicians
The Philips cpap recall is an evolving situation with ongoing consequences. The most immediate challenge has been the supply chain disruption. Pulling millions of devices from the market and restricting a major manufacturer's sales has created widespread shortages, forcing newly diagnosed patients into long waiting lines for life-sustaining treatment.
This delay in therapy increases the risk of heart attacks, strokes, and other serious complications from untreated sleep apnea. Another layer of complexity is the need for long-term health monitoring for millions who may have been exposed to toxic foam, as the full consequences may not be known for years.
Recent safety alerts about overheating in replacement DreamStation 2 devices have only added to patient anxiety, serving as a reminder that medical device safety requires constant vigilance.
The device shortage created by the Philips cpap recall has fundamentally altered the sleep therapy landscape. Widespread shortages and backlogs have become common.
The legal resolution of the Philips cpap recall saw major developments in 2024, providing some clarity for patients.
The future of Philips Respironics in the U.S. market remains uncertain and depends on its ability to meet strict regulatory requirements, a process that could take years.
The Philips cpap recall is one of the most significant medical device safety crises in recent history, affecting over 15 million devices and disrupting sleep apnea treatment for millions. The crisis has evolved from a product recall into a multi-billion dollar legal resolution focused on accountability and patient safety.
Patient safety must always come first. If you use a recalled Philips device, maintain open communication with your healthcare provider. They can help you weigh the risks of continued use against the dangers of untreated sleep apnea. Never stop life-sustaining therapy without medical guidance, as the consequences can be severe.
While Philips has reached settlements totaling nearly $1.6 billion and remediated most registered devices, the road ahead remains complex. New concerns, like the overheating issues with some replacement machines, show that vigilance is still required. The consent decree with the DOJ has created ongoing supply challenges, particularly for newly diagnosed patients.
Understanding your rights is crucial. The cpap recall continues to impact lives, health, and finances. Whether you're dealing with health complications, replacement costs, or the remediation process, you deserve clear information.
At Justice Hero, we simplify complex legal topics like the cpap recall so you can make informed decisions about your health and rights. Our mission is to provide reliable information to consumers seeking justice when corporations prioritize profits over safety.
This is an ongoing issue that requires continued attention. As new developments unfold, staying informed is essential for anyone affected.
