In June 2021, Philips recalled most of its Respironics products, including BiPAP (bilevel positive airway pressure), CPAP (continuous positive airway pressure), and ventilators. The sound abatement foam used in these machines to minimize sound and vibrations breaks down in specific environments, releasing toxic gases and tiny black particles that can cause severe medical complications when swallowed or inhaled, including inflammatory diseases, cancer, and severe respiratory diseases.
The CPAP recall affected millions of people, many of whom used Philips CPAP devices to treat and manage sleep apnea from 2009 to 2021. The affected patients filed lawsuits against Philips, seeking financial compensation for the injuries they suffered.
Background of the Philips Respironics Recall
Philips (Philips Respironics), a leading medical device manufacturer, issued a voluntary recall in June 2021. The recall affected over 10 million medical devices in the United States and more than 15 million devices globally. Philips Respironics recalled the following CPAP, BiPAP, and ventilators, which were manufactured from 2009 to 2021:
- C Series S/T and AVAPS
- C Series ASV (ventilator)
- A Series BiPAP V30 Auto (ventilator)
- DreamStation
- A Series BiPAP A30
- DreamStation ASV
- A Series BiPAP A40 (ventilator)
- DreamStation ST, AVAPS
- Dorma 400 and 500
- A Series BiPAP Hybrid A30
- E30
- DreamStation Go
- Aeris, Garbin, LifeVent ventilators
- OmniLab Advanced +
- REMstar SE Auto
- SystemOne (Q Series)
- SystemOne ASV4
The affected devices were recalled because the PE-PUR (polyester-based) polyurethane foam used in them to abate sound and vibration had degraded, releasing toxic gases and black particles that endangered the lives of patients who inhaled or ingested them. The issues reportedly linked with the PE-PUR polyurethane foam degradation could potentially cause severe injury and require medical treatment to abate permanent damage.
The PE-PUR foam degradation resulted from exposure to hot and humid weather conditions and worsened when recalled devices were cleaned with ozone cleaners not recommended by Philips.
Philips later announced a CPAP machine replacement program to repair and replace the recalled medical devices, but it warned that the process may take up to a year to complete.
In November 2021, the United States Food and Drug Administration (FDA) established that the new foam used in replacement machines was also a potential safety hazard.
Additionally, in January 2022, Philips recalled additional devices, including repair kits and Trilogy Evo ventilators (Models 100 and 200) manufactured between April 2021 and May 2021.
Further, in September and October 2022, the company recalled sleep apnea devices due to contaminated plastic parts in BiPAP devices and CPAP masks with magnets that could interfere with metallic implants.
Linked Health Risks and Injuries
BiPAP, CPAP, and ventilators affected by the Philips CPAP machine safety recall contain PE-PUR polyurethane used to reduce sound and vibration while the machines are operating, which may degrade.
Philips says that toxic gases and black particles released by deteriorated foam may cause cancer and other serious health complications in patients with sleep apnea who use the recalled machines.
A 2022 study assessing 2,571 health complications linked with CPAP machines manufactured between 2014 and 2021 found that at least 4.7% of patients developed cancer after using the affected devices. Other CPAP recall symptoms and risks include:
- Dizziness
- Airways inflammation
- Headache
- Airways irritation
- Nausea
- Eye, skin, nose, and respiratory system irritation
- Vomiting
- Carcinogenic and toxic effects
- Hypersensitivity
- Heart failure
- Heart attack
- Respiratory failure
- Severe ear, nose, and throat inflammation
Moreover, between April 2021 and December 2022, the FDA received over 98,000 reports of health complications associated with the breakdown of PE-PUR foam used in CPAP devices. The reported health problems include dizziness, cough, headaches, and severe complications, like breathing problems, asthma, chest pain, nodules, infections, respiratory issues, and pneumonia. Furthermore, the FDA received 346 reports of deaths associated with the recalled CPAP devices.
In addition, exposure to foam particles in recalled CPAP machines reportedly increased the risk of several cancers, including:
- Brain cancer
- Bladder cancer
- Breast cancer
- Kidney cancer
- Hematopoietic cancer
- Liver cancer
- Leukemia
- Lung cancer
- Lymphatic cancer
- Nasal cancer
- Prostate cancer
- Stomach cancer
- Rectal cancer
- Thyroid cancer
- Testicular cancer
Most of the CPAP cancer symptoms and risks come from chemicals in polyester-based polyurethane foam, such as isocyanates. Isocyanates are made of compounds that are potential human carcinogens and that potentially cause cancer in animals. Also, these compounds cause lung problems and asthma, and some studies show they elevate the risk of developing lung cancer. Philips’ lab analysis revealed that the deteriorated polyurethane produced various harmful chemicals, including toluene diisocyanate, toluene diamine, diethylene glycol, dimethyl diazene, and phenol.
If your CPAP machine was affected by the Philips recall, speak to your doctor about CPAP alternatives. That may mean halting CPAP treatment, finding an alternative, or even exploring alternative sleep apnea treatments, like oral devices, lifestyle changes, or even surgery.
CPAP Recall Lawsuit 2025 Updates
In January 2024, Philips announced a tentative agreement with the FDA. The $400 million settlement offer included a promise by the medical device manufacturer to stop selling CPAP machines in the United States.
Furthermore, in April 2024, Philips agreed to a $1.1 billion compensation settlement related to CPAP litigation. Of that settlement, $1.075 billion will cover personal injury lawsuits that allege its machines caused severe health complications or even death.
$25 million will cover medical monitoring for patients who use CPAP machines and might develop health issues later.
Still, a federal judge must approve the compensation settlement. Suppose the federal court doesn’t approve the settlement. In that case, bellwether trials in the CPAP recall 2025 MDL will occur in 2025 for cases that allege the machines caused people to develop cancer and other severe health conditions. Joy Flowers Conti, a Senior U.S. District Judge, will oversee all the federal Philips CPAP recall 2025 lawsuits.
Attorneys estimate that potential Philips CPAP recall 2025 settlement amounts for cancer injuries will range between $100,000 and $600,000. Based on the severity of the claimant’s injuries, the amount will vary in individual cases.
As of June 2025, there are over 828 pending lawsuits in multidistrict litigation (MDL) over injury allegations linked to recalled CPAP machines.
CPAP Recall Impact on Sleep Apnea Patients
After voluntarily recalling its CPAP machines in June 2021, Philips initially thought it would repair and replace the devices in a year. However, with the recall affecting over 15 million devices globally, the company later stated that it might need more time to repair and replace all the affected units.
That left many sleep apnea patients to choose between using a potentially dangerous medical device or taking risky measures, such as removing the degraded foam themselves, buying second-hand devices online, or doing away with sleep therapy altogether.
The CPAP machines act as a continuous ventilator to keep the airways open during sleep. Untreated sleep apnea can cause one to stop breathing several times during the night, increasing the dangers of dizziness and even heart attack risks.
Thus, many sleep apnea patients are better off with the recalled machines, as the risks associated with the potential dangers of the faulty CPAP are less than the risks of untreated sleep apnea. However, clinicians have been hard-pressed to find alternatives for their patients, which are sadly in short supply due to supply chain issues.
Fortunately for many sleep apnea patients in the United States, in April 2024, a federal district court made a ruling against Philips. The verdict included vital provisions that prioritized patient care and ensured the company’s compliance with regulations.
Further, while denying wrongdoing, Philips agreed to a settlement to resolve the frustrations and uncertainties caused by delays in repairing and replacing recalled devices. The ruling also mandates the company to create a Recall Remediation Plan, offering affected patients partial refunds and replacement machines.
Practical Updates for Affected Users in 2025
In November 2021, Philips Respironics updated its guidelines to correspond with the FDA’s guidance. The medical device maker now advises that patients using affected CPAP and BiPAP machines should consult with their doctor on a suitable treatment alternative.
Philips advises patients using BiPAP and CPAP machines to talk to a doctor to find a suitable treatment option for their medical condition, including:
- Ceasing use of a recalled device.
- Using a similar machine that’s not affected by the recall.
- Continuing to use the recalled machine if the patient’s doctor establishes that the benefits of using that device outweigh the risks reported in the recall alert.
- Using other treatment options for sleep apnea.
The FDA and Philips advise doctors to prescribe their patients CPAP and BiPAP devices that aren’t affected by the recall. However, if this isn’t an option or if other devices are unavailable due to increased demand in the supply chain, then doctors should consider factors such as the severity of symptoms, comorbidities, and safety-sensitive roles. These factors should inform a clinician’s decision on whether to advise their patients to continue or discontinue sleep therapy.
Thus, patients must work with their doctors to understand which machines are affected by the Philips recall and their options for personalized treatment. Sometimes, due to limited supply and other issues, the benefits of continued machine use outweigh the drawbacks.
In June 2021, the MHRA (Medicines and Healthcare Products Regulatory Agency) in the UK issued urgent Field Safety Alerts about the potential risks of stopping treatment with the recalled Philips CPAP machines and the options for using filters instead of ventilator systems. MHRA emphasizes the evidence suggesting the presence of Group 2B carcinogens in the chemicals released by the degraded foam in the recalled CPAP machines and ventilators. Further, the notice points out that diisocyanate is linked to asthma.
Philips offers safety information and recall guidelines for medical professionals and patients, including how they’ll support the maintenance and transition of the recalled machines. Additionally, the American Academy of Sleep Medicine (AASM) offers resources for healthcare providers to understand the impact of the CPAP recall.
If you suffer from obstructive sleep apnea and were affected by the CPAP and BiPAP machines recall, speak to a qualified personal injury attorney as soon as possible to learn about your legal options. A personal injury attorney familiar with the CPAP recall can help you gather comprehensive evidence to prove your claim and recover adequate financial compensation to cover your medical expenses, lost income, and pain and suffering.
At AllConsumer, we partner with various personal attorneys who can help you file your CPAP lawsuit and recover the compensation you deserve. Contact us today to learn how we can help.
