Published March 5, 2026

561 Deaths Linked to Philips CPAP Foam — What Users Need to Know

When Philips Respironics recalled its CPAP, BiPAP, and ventilator devices in June 2021, the company cited the degradation of PE-PUR sound abatement foam as the cause. What followed was one of the most significant adverse event reporting surges in FDA history: more than 116,000 reports filed, including 561 reported deaths.

For millions of users who had been sleeping with these machines for years — breathing pressurized air through degrading foam every night — the recall raised a terrifying question: Had their CPAP been slowly harming them?

What the FDA Data Shows

The FDA's MedWatch and MAUDE (Manufacturer and User Facility Device Experience) databases received a flood of adverse event reports following the June 2021 recall announcement. The reports fell into several categories:

• Physical findings: Users reported visible black particles in their CPAP masks, tubing, and humidifier chambers — physical evidence of foam degradation they had previously been breathing
• Respiratory injuries: Reports of coughing, shortness of breath, respiratory tract irritation, and worsening COPD
• Cancer diagnoses: Reports of lung cancer, kidney cancer, liver cancer, and other malignancies temporally associated with recalled device use
• Deaths: 561 reports of death in connection with recalled device use

The 561 Deaths: What They Mean

The 561 reported deaths are significant — but require careful interpretation.

FDA adverse event reports are voluntary reports submitted by patients, caregivers, and healthcare providers. They document that a person who used the device died, and the reporter believes the device may have been a contributing factor. The FDA does not independently investigate or confirm causation in each individual case.

What's important about the 561 figure is:

• The volume is extraordinary — few medical device recalls generate adverse event report surges of this magnitude
• Many reports describe deaths from cancer diagnoses consistent with carcinogen exposure — the same types of cancers linked to the chemicals identified in foam degradation testing
• The temporal relationship between device use and health outcomes in many reports is consistent with the mechanism of harm alleged in the litigation
• These reports informed the FDA's decision to classify the recall as Class I — the most serious category

What Philips Knew Before the Recall

The most disturbing aspect of the Philips CPAP litigation is the allegation that Philips knew about the foam degradation problem years before the 2021 recall.

According to court filings and regulatory documents:

• Philips was reportedly aware of PE-PUR foam degradation concerns as early as 2015 — six years before the U.S. recall
• The company received complaints about black particles from users before the recall announcement
• Philips issued a field safety notice in some European markets in April 2021 — before telling American patients
• Internal testing reportedly identified toxic and carcinogenic compounds in foam degradation products

If true, these allegations mean that for years, Philips knew its devices were potentially exposing millions of patients to carcinogens — and continued to sell them without adequate warning.

For Families Who Lost a Loved One

If someone you love died and used a recalled Philips CPAP or BiPAP device, the personal injury settlement includes wrongful death claims. Documentation needed includes:

• Evidence that the deceased used a recalled Philips device (prescriptions, purchase records, VA records)
• Medical records documenting the cause and circumstances of death
• Any records showing health conditions developed during or after device use
• Documentation of the temporal relationship between device use and health decline

Wrongful death claims can be brought by surviving family members or the estate. Consulting an attorney who handles MDL 3014 wrongful death claims is an important first step.

What This Means for Living Users

For users who are still alive but concerned about their health, the message is: don't wait to act.

• If you have not had a medical evaluation since the recall, speak with your physician about screening relevant to your exposure history
• If you have been diagnosed with cancer, respiratory disease, or other conditions during or after CPAP use, consult an attorney about your legal rights
• The personal injury settlement fund ($1.1 billion) is designed to compensate users who developed health conditions from foam exposure