On June 14, 2021, a voluntary recall was announced affecting three to four million Philips Respironics CPAP, BiPAP, and mechanical ventilator devices due to potentially serious health risks related to the machine’s sound abatement foam.
A number of products were listed in the FDA’s Recall Notice; however, the FDA has issued an updated notification that identifies nearly 205,000 machines where the highest potential risk exists.
All of these devices, according to the company, were manufactured before April 26, 2021, and were distributed between November 5, 2005, and April 23, 2021.
The sound abatement foam is made of polyester-based polyurethane (PE-PUR) and is used in the breathing machines listed above. This foam may break down into small particles that can enter the device’s mask, tubing, or air pathway where it can be inhaled or swallowed. The foam may off-gas certain chemicals that are dangerous and potentially carcinogenic.
The FDA labels this as a Class I recall, the most serious type of recall.
If you or a loved one developed cancer, respiratory issues, or other serious health problems after using a Philips CPAP machine, contact the law offices of Nash & Franciskato at (877) 284-6600. We will help you determine if your Philips breathing device is the cause of your health issues. One of our experienced staff will speak with you personally and review your case in a free and confidential consultation, with no risk or obligation to take legal action.
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Photo is not of a Philips Respironics product; it is a stock photo to represent the product.
