The encyclopedia · Product & Design · Product decision · 2021
Philips recalled millions of CPAP machines because the sound-foam could be inhaled
The PE-PUR foam used to quiet DreamStation devices could degrade into particles and toxic gases, risking serious injury or death.
Philips Respironics · Philips · 2021-06-14
What happened
In June 2021, Philips Respironics recalled an estimated 15 million CPAP, BiPAP and ventilator devices worldwide. The polyester-based polyurethane foam installed to reduce sound and vibration could break down, releasing black particles and volatile organic compounds into the air pathway.
Users reported headaches, airway irritation, cough and other symptoms; the FDA received over 100,000 adverse-event reports and hundreds of deaths. The agency classified the recall as Class I, its most serious type.
Philips set aside billions for remediation and settlements, agreed to a $1.1 billion settlement for personal-injury and economic claims in 2024, and entered a consent decree with the FDA. The case is now a standard reference for how a material choice made for patient comfort can become a product-safety catastrophe.
Why it happened
- Philips selected PE-PUR foam for sound abatement without sufficient long-term testing under hot, humid and ozone-cleaner conditions.
- Complaints about foam degradation accumulated before the recall, but the company did not act until the pattern became undeniable.
- The global device base was so large that even a low failure rate translated into millions of affected patients.
- The repair and replacement program struggled to keep pace, prolonging exposure for users who depended on the devices.
The lesson
A material chosen for comfort must be tested for the full life of the device in real-use conditions — and complaint signals must be treated as safety data, not noise.
Aftermath
Philips paid a $1.1 billion settlement, entered a consent decree, and its Sleep & Respiratory Care business was constrained. Competitors gained market share during the recall.
Sources
- Philips Respironics Recall of Positive Airway Pressure Devices — NIH/PMC
- Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines — U.S. Food & Drug Administration
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