On June 14, 2021, Philips Respironics announced a voluntary recall covering approximately 15 to 16 million CPAP, BiPAP, and mechanical ventilator devices worldwide — including roughly 5.5 million units sold in the United States. The FDA immediately classified it as a Class I recall, its most serious category, indicating that the recalled devices posed a risk of serious injury or death. The cause: PE-PUR (polyester-based polyurethane) foam used as a sound-dampening component inside the devices was found to degrade and release toxic chemicals directly into the breathing pathway of users.

The recall covers DreamStation (all variants), System One 50 and 60 Series, REMstar SE Auto CPAP, Dorma 400 and 500, OmniLab Advanced+, A-Series BiPAP A30 and A40, and Trilogy 100 and 200 ventilators. Devices manufactured between approximately 2009 and 2021 are included. The DreamStation is the most common device among plaintiffs in MDL 3014.

FDA testing identified over 200 chemical compounds released by degraded PE-PUR foam, including toluene diisocyanate (TDI — a known respiratory carcinogen), dimethylformamide (DMFA), diethylene glycol, and N,N-dimethylacetamide. These chemicals are inhaled nightly during sleep, with the nasopharynx, lungs, and systemic circulation receiving the greatest exposure. Ozone-based CPAP cleaners dramatically accelerate foam degradation and increase chemical off-gassing.