The recall of Philips' respiratory devices due to the use of silicone foam as a substitute for problematic foam has once again come under the spotlight. Reports indicate that the company is accused of concealing adverse event reports, selling defective products, and the silicone foam substitute releasing formaldehyde and other dangerous chemicals.

 

The supervision of the U.S. Food and Drug Administration (FDA) in this incident has also been called into question, with accusations that it failed to take timely action to protect patients from harm. Moreover, the DreamStation 2 CPAP ventilator, which is a replacement for the recalled devices, poses an overheating risk, potentially leading to burns, smoke, and fires.

These accusations and events have triggered public concerns about Philips Respironics and the regulatory efforts of the FDA.