PE-PUR (polyester-based polyurethane) sound-abatement foam · Philips Respironics (Koninklijke Philips N.V.) · updated June 2026
Plaintiffs allege that the polyester-based polyurethane (PE-PUR) sound-abatement foam in recalled Philips Respironics CPAP, BiPAP, and ventilator machines can degrade and release particles and chemicals that, they claim, caused cancer and respiratory injuries. Philips recalled roughly 15 million devices worldwide beginning in June 2021 in what the FDA classified as a Class I recall, and the company has agreed to a settlement of about $1.1 billion to resolve personal-injury claims. These remain allegations; causation has not been established in court, and the settlement is not an admission of liability.
This page is general information about ongoing litigation and FDA safety actions — not medical or legal advice, and not a statement that Philips CPAP caused any injury. Allegations described here are claims that have not been proven in court. Always consult a licensed professional.
Plaintiffs allege that the PE-PUR sound-abatement foam used inside Philips Respironics CPAP, BiPAP, and mechanical-ventilator machines can break down — particularly under heat, humidity, and certain cleaning methods — and release black foam particles and volatile chemicals (such as toluene diisocyanate and related compounds) into the device's air pathway, which users then allegedly inhale or swallow. They claim this exposure caused cancers, respiratory illnesses, and inflammatory injuries, and that Philips knew or should have known about the foam-degradation risk years before issuing the June 2021 recall yet failed to warn patients and regulators. These are allegations only; causation has not been proven in court, the science remains disputed, and a manufacturer's settlement is not an admission of liability. This entry is informational and is not legal advice.
In June 2021, Philips Respironics issued a voluntary recall of certain CPAP, BiPAP, and ventilator devices (roughly 15 million units worldwide) over degrading PE-PUR sound-abatement foam, which the FDA designated a Class I recall — its most serious category, reserved for situations with a reasonable probability of serious injury or death. Since April 2021, the FDA has received more than 116,000 medical device reports tied to the foam breakdown, including hundreds of reports of death (561 as of recent FDA tallies), though such reports do not by themselves establish that the devices caused the outcomes. On April 9, 2024, a federal court (W.D. Pa.) entered an FDA/DOJ consent decree against Philips Respironics requiring a recall-remediation plan and regulatory compliance, and restricting new U.S. sleep-and-respiratory-device production and sales at certain facilities until specified requirements are met.
MDL No. 3014, In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation, is pending in the U.S. District Court for the Western District of Pennsylvania before Senior Judge Joy Flowers Conti. As of mid-2026, roughly 600 personal-injury cases remained consolidated in the MDL. Philips agreed to a settlement of about $1.1 billion (announced April 29, 2024) to resolve U.S. personal-injury claims — approximately $1.075 billion for personal injury plus $25 million for medical monitoring — which is separate from an earlier $479 million economic-loss class-action settlement reached in September 2023. Philips denies liability and maintains the devices did not cause injury. Settlement administration and resolution of remaining cases were ongoing as of mid-2026.