The agency, in a statement issued last week, said it has received more than 116,000 reports about the breathing devices — BiPAP and CPAP machines — over nearly three years.

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PLEASANT HILLS, Pa. — Philips Respironics has promised to replace millions of CPAP and BiPAP breathing machines that FDA reports have linked to thousands of injuries and more than 300 deaths.

In 2021, polyester-based polyurethane (PE-PUR) foam used in Philips Respironics ventilators, CPAP and BiPAP machines was found to degrade and cause serious health issues or death, leading to a ...

The agency, in a statement issued last week, said it has received more than 116,000 reports about the breathing devices — BiPAP and CPAP machines — over nearly three years.