Philips CPAP Recall Lawsuit
Breathing Device Foam Degradation

Philips Respironics issued the largest breathing device recall in history on June 14, 2021, affecting approximately 15 million CPAP (Continuous Positive Airway Pressure), BiPAP (Bilevel PAP), and mechanical ventilator devices worldwide—including 3-4 million devices in the United States.

The recall was triggered by a critical problem: the PE-PUR sound abatement foam used inside these life-critical breathing devices degrades over time, breaking down into black particulate matter and volatile organic compounds (VOCs) including toluene diisocyanate (TDI) and toluene diamine (TDA)—chemicals that users inhale directly into their lungs during 6-8 hours of nightly sleep therapy.

By May 2024, Philips agreed to settle personal injury claims for $1.075 billion (plus a separate $25 million medical monitoring fund). The settlement was finalized on January 31, 2025, with settlement payments made to eligible claimants during the first half of 2025.

Sleep apnea is a serious sleep disorder in which a person's breathing repeatedly stops and starts during sleep—sometimes dozens or hundreds of times per night. This interrupts oxygen delivery to the brain and body, increasing the risk of heart attack, stroke, arrhythmias, and sudden death.

CPAP therapy is the gold-standard treatment. A CPAP machine delivers pressurized air through a mask worn over the nose (or nose and mouth) throughout the night, keeping the airway open. Patients must use CPAP devices for 6-8 hours every night to prevent dangerous breathing interruptions. BiPAP devices provide two pressure levels (one for inhalation, one for exhalation) for patients who find CPAP uncomfortable.

Patients cannot simply stop using these devices. Unlike optional consumer products, sleep apnea treatment is medically necessary—sudden discontinuation puts patients at immediate risk of life-threatening events. This created a serious dilemma when the foam degradation was discovered: patients faced a choice between continued therapy with potentially toxic foam or abandoning necessary treatment.

Philips Respironics is a division of Dutch conglomerate Koninklijke Philips N.V. and was the world's second-largest manufacturer of CPAP devices. The company manufactured and distributed breathing therapy devices globally for over a decade before discovering the foam degradation issue.

The recalled devices span three major categories manufactured between 2009 and April 2021:

Each device contains a PE-PUR (polyether polyurethane) foam block designed to dampen noise from the motor and air flow. Over time, this foam degrades due to heat, humidity, ozone, and cleaning agents, releasing toxic particles that patients inhale directly.

The PE-PUR foam used in these devices is susceptible to degradation through several mechanisms:

• • Heat exposure — Device motors generate heat; bedroom temperatures fluctuate
• • Humidity — Condensation in the device from humidified air; tropical climates accelerate breakdown
• • Ozone exposure — Air purifiers with ozone generators, certain cleaning products create ozone
• • Cleaning agents — Isopropyl alcohol, bleach, vinegar used to clean devices accelerate foam breakdown

When the foam breaks down, it releases:

During litigation, a dispute emerged over whether the foam degradation products posed genuine health risks. Philips argued that degradation was minimal and posed no safety threat. However, the FDA stated in October 2023 that Philips' testing was "inadequate" to demonstrate safety. The Trilogy foam even failed genotoxicity testing—a key indicator of potential genetic damage.

The FDA's response to Philips escalated from initial notification through consent decree:

Plaintiffs in this MDL allege that the foam degradation and inhalation of toxic chemicals caused various serious health injuries:

Additional reported symptoms include headaches, dizziness, nausea, sinus problems, and fatigue. Some plaintiffs report accumulating black particles in the device humidifier chamber or seeing visible foam deterioration.

The FDA received 116,000+ medical device reports (MDRs) related to this recall, including 561 death reports. However, the scientific community remains divided on causality—some epidemiological studies have not established a definitive link between foam exposure and specific cancers, while the FDA maintains that the health risk remains significant enough to warrant the Class I recall and permanent injunction.

While the civil MDL settlement was finalized, multiple investigations and legal proceedings continue against Philips and its executives:

Key Defendants: Philips North America LLC, Philips RS North America LLC, Koninklijke Philips N.V. (Dutch parent), and CEO Roy Jakobs have been named as defendants in various proceedings.