The US Food And Drug Administration Considers The Phillips CPAP Recall Efforts To Be Ineffective

The number of CPAP patients that are unaware of the recall prompted an FDA warning letter to be sent to Phillips

Friday, March 18, 2022 - Phillips Respironics may be in as much trouble with the US government as it is with thousands of their customers that have filed Phillips CPAP lawsuits after developing lung, throat, and mouth cancer from using the devices allegedly. On March 10, 2022, the U.S. Food & Drug Administration (FDA) issued a formal complaint to the company that addressed their poor handling of the Phillips CPAP recall order issued on April 23, 2021. It seems that the Dutch company has dragged its feet and failed to contact registered owners of their ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) devices to tell them of the products' deadly defects, to stop using the device, and of their willingness to immediately repair and replace the machine. Phillips CPAP lawsuits are being filed by users that have developed a variety of breathing problems including lung cancer. According to the FDA's warning letter, "FDA has determined that the degradation of the PE-PUR sound abatement foam and the potential for debris to be released into the device�s air pathway has caused the Recalled Products to present an unreasonable risk of substantial harm to the public health. Particulate matter small enough to stay airborne can be inhaled through the nose (nasal route) or the mouth (oral route)." An unacceptable number of Phillips CPAP users have complained to the FDA that they have not received any notice of the recall from Phillips and others have said they were unaware of any recall efforts at all. 28 of the 180 people that were contacted by the FDA told the health agency that this was the first time hearing about the recall. The FDA says that this raises concerns about the overall effectiveness of the recall campaign. Only around 50% of Phillips CPAP users have responded and asked for a refund. The FDA warning letter demands that Phillips make another attempt to contact their customers and to tell them about the problems with the device and that the FDA issue a stern recall notice.

Also of concern to the FDA is the way the company hedged the serious health problems caused by the device's noise cancellation foam. The company's CEO went on record as blaming SoClean Ozone cleaning solution for being solely responsible for the devices malfunctioning and implying to those CPAP owners that were not using this particular cleaning solution their device was not affected, and to continue using it. The Phillips website home page continues to downplay the serious nature of the recall which the FDA describes as serious and life-threatening. Phillips CPAP sleep apnea users have complained of finding black particles in the clear airway passage of the machine caused by the degradation of the device's sound abatement foam. The foam's decomposition also releases toxic, possibly carcinogenic gasses and chemicals directly into the CPAP airway and the user breathes these toxins into their lungs continuously throughout the night.

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