For nearly a year, millions of Americans who use CPAP devices to treat sleep apnea have been left up in the air due to a massive recall by Philips Respironics. The medical device manufacturing company began a voluntary recall of CPAP, BiPAP, and ventilator devices in June of 2021. However, because of the scale of the recall, millions of people have not yet been able to receive replacement devices, and many have been forced to choose between going without treatment or potentially putting themselves at risk of harm through the use of devices that may be unsafe. Multiple agencies in the United States government have been looking into the recall, and they may take action against Philips to address the ways consumers have been affected.
Actions Taken Against Philips by the FDA and DOJ
Philips began its recall of CPAP machines and similar devices because it learned that the products contained a dangerous substance that could break down over time. A polyester-polyurethane foam had been used in these devices to dampen sound and help them operate more quietly. Unfortunately, the breakdown of this foam may have led users of the devices to inhale tiny particles and toxic chemicals, leading to potential lung injuries and other health issues.
While Philips announced the recall in June 2021, company records indicate that it knew about the potential health hazards for months or years and failed to take action. After announcing the recall, the company has struggled to ensure that consumers and medical device suppliers are informed about the issue, and many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) has been overseeing the recall, and it recently issued an order requiring Philips to create more effective notification procedures.
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