WASHINGTON — Medical equipment company Philips Respironics has recalled at least 17 million masks used with breathing devices designed to treat patients with sleep apnea and other respiratory conditions, federal health officials announced this week.
In a Tuesday news release, the U.S. Food and Drug Administration said a “serious safety concern” with magnets prompted the recall of the products, which are worn with bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) devices. The affected masks include the Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP, the agency said.
“The recalled masks are worn by a person when using a BiPAP or CPAP machine and have magnets that connect the mask components to hold the device in place,” the release said. “The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices.”
BiPAP and CPAP machines help people with obstructive sleep apnea, respiratory insufficiency, or respiratory failure — health conditions that cause pauses in breathing during sleep.
— U.S. FDA (@US_FDA) September 6, 2022
The FDA said the magnets could cause problems with pacemakers, aneurysm clips, implantable cardioverter defibrillators, metallic stents and other medical devices, WAFB-TV reported. Additionally, the recalled masks could affect patients and people nearby “who have metallic objects in their body, such as shrapnel or splinters in their eyes,” according to the FDA news release.
The FDA recommended that patients who have – or sleep near people who have – implanted medical devices or objects “stop use of the recalled mask and switch to a non-magnetic mask if available.”
“You may continue using the mask, if you or someone near you when using the recalled mask, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks,” the agency continued.
Philips has received at least 14 reports of serious injuries linked to the recalled masks, the FDA said. No deaths have been reported, according to the agency.
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