If you use a sleep apnea mask or have a family member who does, there's an urgent message about a recall because of a device that's been connected to hundreds of deaths.

Piece of Foam Inside Sleep Apnea Machine Could Result in Injury

According to a press release from the FDA, the recall of CPAP machines due to a breakdown in the polyurethane foam was originally released in November 2021.

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Philips ventilators, BiPAP machines, and CPAP machines were recalled because of a serious issue that "could potentially result in serious injury and require medical intervention to prevent permanent injury."

The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.

Devices made by Philips from 2009 to April 26, 2021, are on the recall list including certain Trilogy Evo Ventilators that were shipped between April 15, 2021, to May 24, 2021.

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To check the serial numbers and confirm if a sleep apnea mask you're using is on the list, CLICK HERE.

More Than 500 Deaths Linked to Recalled Sleep Apnea Masks

According to a press release from the Food and Drug Administration, there have been over 116,000 medical device reports made from Philips that were associated with sleep apnea masks having "the PE-PUR foam breakdown or suspected foam breakdown."

561 deaths have been linked to sleep apnea mask breakdowns since April 2021, according to the press release.

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There were 111 deaths associated with these sleep apnea masks from just July 1, 2023 through September 30, 2023.

For more details about the Sleep Apnea Mask recall, CLICK HERE.

 

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