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Blumenthal & Tong Demand Urgent FDA Action to Protect Against Defective Philips Breathing Machines as Connecticut Consumers Raise Alarm

15 million Philips sleep apnea machines have been recalled due to risk of cancer & new FDA investigation reveals fix to the problem is potentially unsafe, Connecticut constituents have reported serious health effects due to their inability to use their CPAP devices, struggles with finding safe alternatives & inadequate responses from the manufacturer

[HARTFORD, CT] – Following a new federal investigation revealing that a fix to the Philips sleeping machine recall poses significant risks to patients, U.S. Senator Richard Blumenthal (D-CT) and Connecticut Attorney General William Tong called on the U.S. Food and Drug Administration (FDA) to take immediate action to protect millions of Americans—and thousands of Connecticut residents—impacted by the recall of Philips CPAP, BiPAP, and other ventilator machines. Blumenthal and Tong urged strong FDA action at an event earlier today with affected Connecticut residents and a local doctor.

“FDA must take swift and aggressive enforcement action against Philips, including steps necessary to remedy this situation as quickly as possible, so that device users now and into the future can trust that the life-saving and life-sustaining products they use are safe,” wrote Blumenthal and Tong to FDA Acting Commissioner Janet Woodcock.

Blumenthal and Tong’s offices have heard from dozens of alarmed Connecticut residents who have been affected by the recall.

“Connecticut constituents have expressed alarm that the FDA and Philips have failed to put in place a transparent plan to mitigate the now-clear carcinogenic risks associated with these devices, despite multiple warnings to consumers,” wrote Blumenthal and Tong. “They have also reported increases in secondary weight gain, blood pressure, anxiety, and insomnia as a result of their inability to use their C-PAP devices. Others are considering paying hundreds of dollars to replace their devices, while running into supply shortages of alternatives. Furthermore, despite making repeated calls to Phillips, these constituents report receiving inadequate answers from the company as to when they can expect a replacement device.”

Blumenthal and Tong have also been contacted by medical professionals who are concerned about their patients: “Our offices have also heard from doctors who say that the failure to provide timely replacement of the recalled machines will continue to dramatically worsen comorbid conditions such as hypertension, obesity, diabetes, coronary artery disease, and congestive heart failure.”

In June 2021, Philips Respironics, a subsidiary of Philips North America, recalled more than 15 million breathing machines manufactured between 2009 and 2021 due to problems involving the polyester polyurethane foam used in the machine. The foam can degrade over time, resulting in small inhalable particles that can cause significant health issues, including cancer. The FDA classified this as a Class I recall—the most serious type of recall—due to grave health risks stemming from a sound abatement foam in the machines. A recent FDA investigation revealed that the silicone-based foam Philips has been providing to consumers in replacement machines is potentially unsafe, possibly renewing the risk to consumers.

The full text of today’s letter is available here.