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# Senator Calls on FDA to Probe Respironics
- URL: https://www.fdaweb.com/senator-calls-on-fda-to-probe-respironics/
- Published: 2023-10-11T12:00:00.000Z
- Updated: 2026-09-14T19:01:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155543

Sen. **Richard Blumenthal** (D-CT) is now urging FDA to investigate whether Philips Respironics criminally hid complaints about its faulty CPAP breathing devices over the course of 11 years before launching a massive recall in 2021\. Last week, the senator asked the Department of Justice (DoJ) to investigate the company after a recent [report by ProPublica](https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared?ref=fdaweb.com) and the [Pittsburgh Post-Gazette](https://newsinteractive.post-gazette.com/philips-respironics-cpap-defect-recall/?ref=fdaweb.com) revealed that it kept secret more than 3,700 complaints about its faulty CPAP breathing devices ([see earlier story](https://www.fdaweb.com/senator-urges-justice-probe-of-respironics/)).

In a [10/10 letter](https://www.documentcloud.org/documents/24024529-101023-letter-to-fda-and-doj-re-philips-investigation-final?ref=fdaweb.com), Blumenthal now urges FDA to investigate these allegations thoroughly, “taking the strongest enforcement action possible, including criminal charges, if the allegations are substantiated.” According to the investigative report from the news outlets, “persistent problems show that for over a decade, safety policies and procedures in place at Philips were inadequate, complaints were not timely acted on or fully disclosed, and alarming test results were ignored,” he says in the letter.

“Even after a formal investigation was finally initiated in 2019,” Blumenthal continues, “no substantive action was taken until the dangerously defective breathing devices were subject to a mass recall in the middle of 2021\. As a result, we may not know the full impact of Philips’ negligence for years to come. That is why it is imperative for FDA and DOJ to take swift and aggressive investigatory and enforcement action against Philips to deter future wrongdoing and hold the company accountable for past violations.”

Meanwhile, safety tests on the foam by Philips following the recall were called into question by CDRH 10/5 ([see earlier story](https://www.fdaweb.com/fda-unsatisfied-with-philips-respironics-recall/)), saying they were inadequate and did not “fully evaluate the risks posed to users… Although Philips concluded that the exposure to foam particles and volatile organic compounds from these devices is ‘unlikely to result in an appreciable harm to health in patients,’ FDA believes additional testing is necessary. Philips has agreed to conduct the additional testing. Based on the currently available information, FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”