Philips CPAP Recall Lawsuit: The $1.1 Billion Settlement

By James J. Rosemergy, Carey & Danis LLC  |  Last updated: May 11, 2026

The Philips CPAP recall lawsuit stands as one of the largest medical device mass torts in U.S. history. In June 2021, Philips Respironics — the world’s leading manufacturer of CPAP and BiPAP sleep apnea devices — recalled approximately 10.8 million devices in the United States after discovering that foam inside the machines could break down and release toxic particles and chemical gases directly into users’ breathing pathways. Years of litigation culminated in a $1.075 billion personal injury settlement and a separate $479 million economic loss settlement. This page provides a complete informational overview of what happened, how the litigation resolved, and what former device users should know.

What Happened With the Philips CPAP Recall?

On June 14, 2021, Philips Respironics announced a voluntary recall covering its CPAP, BiPAP (Bi-Level PAP), and certain mechanical ventilator devices — products that millions of Americans relied upon every night to treat sleep apnea and other serious respiratory conditions. The recall was triggered by a critical safety discovery: the polyester-based polyurethane (PE-PUR) foam that Philips used inside these devices to muffle operational noise could degrade over time.

When the PE-PUR foam broke down, it released both foam particles and volatile chemical gases directly into the air pathway that users breathed through each night. Testing identified that the off-gassing compounds included substances classified by health authorities as possible or probable human carcinogens. Many affected users had been sleeping with these devices for a decade or more — unknowingly inhaling degradation byproducts night after night.

The degradation risk was compounded by how users cleaned their devices. Ozone-based cleaning machines — widely marketed to CPAP users as a convenient sanitizing solution — were found to accelerate PE-PUR foam breakdown, increasing the rate and volume of harmful emissions. Heat and humidity also contributed to degradation, meaning users in warm climates or those who stored devices improperly faced elevated risk.

The recall was not limited to a small subset of products. It covered numerous CPAP, BiPAP, and ventilator models primarily manufactured between 2009 and 2021. Philips published full model lists in coordination with the U.S. Food and Drug Administration. Importantly, not all Philips devices were recalled — models using a different foam formulation were excluded — but the scope of affected products was massive.

What Philips Knew — and When

Evidence developed in litigation suggested that Philips was aware of potential foam degradation issues years before the June 2021 recall announcement. Internal complaints and quality reports became a focus of discovery, raising questions about whether the company delayed its recall response while consumers continued using potentially dangerous devices. These facts formed the factual foundation of the personal injury claims that followed.

The FDA’s Response to the Philips Recall

The U.S. Food and Drug Administration’s response to the Philips recall escalated significantly over the three years following the June 2021 announcement. The FDA issued multiple safety communications, conducted inspections of Philips manufacturing facilities, and monitored the company’s repair and replacement program — which proved far slower than patients and regulators expected, leaving millions of people without safe equipment for extended periods.

The FDA’s enforcement posture ultimately hardened into formal legal action. In April 2024, the agency entered a consent decree of permanent injunction against Philips — a binding federal court order restricting Philips’s ability to manufacture and distribute sleep therapy devices in the United States and requiring the company to undertake specific corrective measures under ongoing federal oversight. You can review the FDA’s announcement of the consent decree on the agency’s website.

In a significant development that marked the effective end of Philips’s U.S. sleep therapy business, the company subsequently announced it would cease selling CPAP and BiPAP devices in the U.S. market entirely — exiting the business it had dominated for decades.

The Litigation: MDL 3014 in Western Pennsylvania

Federal lawsuits against Philips began within weeks of the recall announcement and multiplied rapidly. By late 2021, the U.S. Judicial Panel on Multidistrict Litigation had consolidated the federal cases into MDL 3014 — formally titled In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation — before Judge Joy Flowers Conti in the Western District of Pennsylvania in Pittsburgh.

The MDL addressed two legally and factually distinct categories of harm, which proceeded on separate tracks:

Personal injury claims alleged that prolonged daily use of recalled devices — and years of inhaling degraded foam particles and chemical emissions — caused cancer, serious respiratory disease, and other significant medical conditions. These cases required individualized medical evidence connecting specific diagnoses to recalled device exposure, making each case factually intensive.

Economic loss claims were brought as a nationwide class action by consumers who had purchased or leased recalled devices, seeking compensation for the devices’ cost and diminished value — without requiring proof of a physical diagnosis.

Attorneys at Carey & Danis were active participants in the litigation, representing one of the named plaintiffs on the economic loss and medical monitoring claims, working on the Science and Expert Committee to develop critical evidence in the case generally, and representing individual clients with personal injury claims.

How the Philips CPAP Lawsuit Was Resolved

The two litigation tracks reached resolution separately, through distinct settlement mechanisms negotiated over more than two years of litigation.

Economic Loss Class Action — $479 Million (September 2023)

Philips settled the consumer economic loss class action for $479 million, providing payments ranging from approximately $50 to $1,500 per device to eligible class members who had purchased or leased a recalled device. The claims submission period for this settlement closed in August 2024.

Personal Injury Master Settlement Agreement — $1.075 Billion (May 9, 2024)

After more than two years of litigation, Philips and plaintiffs’ negotiating counsel executed a Master Settlement Agreement on May 9, 2024, allocating $1.075 billion for personal injury claims. To participate, claimants represented by an attorney were required to have been enrolled in an Identification Order Declaration before June 21, 2024, and to have retained their attorney before April 29, 2024. The registration process — requiring a Registration Form, signed Release, and Stipulation of Dismissal — closed January 31, 2025, with a supplementation period extending to February 20, 2025.

Medical Monitoring Fund — $25 Million

An additional $25 million was set aside to fund medical monitoring research for the millions of class members who used recalled devices but had not yet developed a qualifying diagnosis. This fund acknowledges the potential for latent health effects from long-term foam exposure and supports ongoing study of affected populations.

Emerging Injury Fund (EIF)

The settlement structure included a limited Emerging Injury Fund for individuals who receive a qualifying new diagnosis after April 29, 2024 — providing a potential pathway for claimants whose conditions had not yet manifested at the time the settlement was finalized. If you have recently received a cancer diagnosis you believe is linked to a recalled Philips device, consult an attorney promptly to evaluate whether this fund may apply to your situation.

Key Considerations for Former Philips Device Users

Former Philips CPAP and BiPAP users who have concerns about their health following the recall should keep a few important points in mind.

First, not every health condition experienced by a recalled device user is necessarily related to foam degradation. Individual causation is a medical and legal question that requires evaluation of specific facts, including duration of device use, model type, cleaning method, and medical history. Your physician is the right starting point for health concerns.

Second, the main settlement registration processes are now closed for most claimants. The personal injury registration deadline was January 31, 2025, and the economic loss claims period closed in August 2024. For most people, the window to participate in these programs has passed.

Third, the FDA’s $25 million medical monitoring fund is a research fund — it supports population-level studies into health effects from recalled device use and does not provide direct compensation to individual claimants outside of the settlement program.

Frequently Asked Questions