As many as 2 million people in the US use CPAP breathing machines made by Philips that have been recalled—and they're struggling to get the machines fixed or replaced. The company recalled a number of CPAP (continuous positive airway pressure) machines as well as BiPAP (bilevel positive airway pressure) machines and ventilators; the FDA has the complete list here and Philips has it here. Black debris from the polyester-based polyurethane sound abatement foam used in the machines can break down and get into the machines' air pathways, thus potentially being inhaled or swallowed by the user. This can cause serious medical issues; the FDA has classified the recall as a Class I, the most serious class, which means continued use of the devices can lead to serious injuries or death.
There have been more than 1,200 complaints about the devices and more than 100 injuries reported. Philips plans to issue repair kits (which will replace the foam with a silicone version) or replacement devices, but has so far only been able to produce 55,000 per week—which they can't even send out because they don't yet have FDA clearance, WBAL reports. It estimates it will take a year to replace or fix all the machines, the Wall Street Journal reports. That has left many sleep apnea sufferers, who use the machines to ensure they don't stop breathing at night, wondering whether to stop using their machines (and risk heart and lung issues or uncontrolled blood pressure), keep using them despite the risks, try to remove the foam themselves, or purchase pricey new ones not knowing whether they'll be reimbursed by insurance. Those who choose that final option may not even be able to find one to buy: increased demand has led to inflated prices and a shortage of machines. (Read more sleep apnea stories.)