For three years, Donald Camp has used a breathing device to sleep. He has severe sleep apnea, so without this device, his breathing is obstructed and he gasps for air.
But in June, Mr. Camp and many others began learning that more than a dozen Philips Respironics machines that deliver pressurized air through a mask were recalled because of potential health risks from faulty components. Since then, millions of people in the United States, and their doctors, have been scrambling to find alternatives for those with common sleep disorders, breathing problems and respiratory emergencies.
Last month, the Food and Drug Administration warned of potential health risks that could be “life-threatening, cause permanent impairment and require medical intervention.” The potential harm comes from polyester-based polyurethane foam that dampens sound and vibration in the machines; it can degrade and result in a user’s breathing in chemicals or swallowing or inhaling black debris.