Editing Philips Respironics (section)

== Hazardous foam and product recall==
A redesign of the [[CPAP]] devices{{Which|date=October 2023}} from Respironics led to over a decade of complaints to Philips, which withheld the vast majority of them from the U.S. [[Food and Drug Administration]] (FDA). Around 2010, the company added industrial foam made of [[polyester]]-based [[polyurethane]] to silence rattling in the machine. But the foam could fall apart in heat and [[humidity]], sending it into patients' noses, mouths, throats, and lungs. Among the chemicals released was [[formaldehyde]], a potential [[carcinogen]].<ref name=":0" />  

In 2023, replacement units and models were found to also emit detectable levels of formaldehyde.<ref>{{Cite web |last=by Debbie Cenziper, ProPublica; Michael D. Sallah and Evan Robinson-Johnson, Pittsburgh Post-Gazette; and Margaret Fleming, Medill Investigative Lab |first= |date=2023-12-28 |title=Philips Recalled Breathing Machines in 2021. Chemicals of “Concern” Found in Replacement Machines Raised New Alarm. |url=https://www.propublica.org/article/philips-recall-machines-chemicals-of-concern |access-date=2025-05-08 |website=Dec2023ProPublica |language=en |ref=ProPublica}}</ref>

Only in 2021 did Philips recall the machines, which had been delivered across the United States and many other countries. Over 3,700 complaints across more than 11 years were held back from the FDA, which device makers are required to do so within 30 days of reports of patient injuries in addition to investigating them. The company did not begin an internal investigation until 2019. The devices were used by children, the elderly, and over 700,000 U.S. veterans. As many as 15 million devices were affected. People experienced [[vomiting]], [[dizziness]], [[headaches]], and cancers in the [[Lung cancer|lungs]], [[Throat Cancer|throat]], [[Sinus cancer|sinuses]], and [[Esophageal cancer|esophagus]]. Company officials knew about the dangers of the device, but continued to market and sell them.<ref name=":0" />

During the [[COVID-19 pandemic]], the company ramped up production of another ventilator that also included the foam. Operating profits from the ventilators, including the CPAP devices, soared to around US$800 million/year. During the pandemic, Philips conducted a series of studies on the foam, showing the deteriorating foam and chemicals released by it, could cause "serious injury, life-threatening or permanent impairment".<ref name=":0" />

The company said patients' health is its top priority, and regretted the "distress and concern" that the recall caused. It said complaints about the foam were limited and were evaluated on a case-by-case basis, and it was made aware of the significance in early 2021, launching the recall soon after. Months after the recall, Philips said that tests showed the chemicals released by the foam were within safe levels.<ref name=":0" />{{Peacock inline|date=May 2025}}

The company announced a new CPAP machine in April 2021, and soon after admitted that the foam it had used previously had been breaking down in an earnings call. Then-CEO [[Frans van Houten]], in the earnings call, pledged 250 million euros to the problem, and reassured investors that the "device is safe to be continued to use to the best of our knowledge at this time". The company alerted the FDA but not customers. Following the recall, van Houten said he regretted the impact of it on "patients, care providers, and shareholders."<ref name=":0" />

Multiple federal lawsuits have been levied against the company. One settled with the company for US$479 million to reimburse customers.<ref>{{Cite news |last=Jewett |first=Christina |date=September 7, 2023 |title=CPAP Maker Reaches $479 Million Settlement on Breathing Device Defects |work=[[The New York Times]] |url=https://www.nytimes.com/2023/09/07/health/cpap-defect-recall-philips-respironics.html |access-date=November 28, 2023 |issn=0362-4331}}</ref><ref name=":0" /> This increased to US$1.1 billion in 2024.<ref name=":1">{{Cite web |date=February 19, 2025 |title=Respironics FAQ |url=https://www.philips.com/c-dam/assets/corporate/global/investor/Respironics_FAQ_February_19_2025.pdf |website=Philips Investor Info}}</ref> A shareholder class action remains outstanding.<ref name=":1" />