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# Justice Department Probe on Philips Respironics Recall
- URL: https://www.fdaweb.com/justice-department-probe-on-philips-respironics-recall/
- Published: 2022-04-26T12:00:00.000Z
- Updated: 2026-09-14T17:42:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151684

Philips Respironics and certain Philips subsidiaries in the U.S. recently received a subpoena from the Department of Justice for information on the events that led to the recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, according to a first quarter earnings call by parent company Royal Phillips.

“Receiving a request for information under these circumstances is not out of the ordinary,” Philips CEO **Frans van Houten** said on the call. “At this time, the subpoena is a request for information focused on Philips Respironics to support their investigation and we are not aware of any specific allegations. Respironics and other U.S. subsidiaries are fully cooperating.”

News of the Justice Department’s probe comes a little more than a month after FDA issued a rare [Section 518(a)](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZH-2F-2BdT2Hfvce-2B9YoPQjyr3NbUdLzFfkAclTghtHjy3-2Bt7UGomlqrF-2BFUfe-2BO7kt7I-2FIQ0skxfLYWNV3TTrOX683mX7h-2FS99mS256-2BEQdNu2U9BXfQjOC-2FylbJPJ4m655Ufyx2TccpPbJwti-2FJwICMR4-3Dnr2F%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigCiXICIZPB4RGigCdTzpK2QgEtecQr07-2BqexlLIBD5kNw-2FavX-2BYh44pnfMa5xoVEfZ7c4fPTuxxLTO6Td0XyBUFDw0jqyBYL9AtNHmnJxERaTLj7pnnzkbgC4GWXLMPVWu3m2aR3zMnuyOCMPLjWQfaeuE-2BCI-2BCfREgc2ey8ZTGplX59tX-2BosOHyd7oXqzfeyxOCs-2BatljpQSp9PlbHqH6Ftg2e0q6psOM-2B-2BTgEbsWmBaeKAXN-2BcIMvdDZuNDfZgRbX2AFtVfvD0q-2FtlNZv2JYUk-2F-2BN2n9T6OPNcTV2cBcvU-3D&ref=fdaweb.com) notification order ([see story](https://www.fdaweb.com/philips-hit-with-rare-518-a-order-on-ventilators/)) to Philips Respironics requiring it to notify patients and others of the company’s 6/14/2021 recall of the ventilators, CPAP and BiPAP machines, and the “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane sound abatement foam used in those products.” The [notification order](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZAmdierth9sDznGHUIlSHO9ei4TFsJLd8vCd6yy0SwYqCDyl3PlnVprxjkojIZPkAA-3D-3DdWuB%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigCiXICIZPB4RGigCdTzpK2QgEtecQr07-2BqexlLIBD5kNw-2FavX-2BYh44pnfMa5xoVEfZ7c4fPTuxxLTO6Td0XyBUFDw0jqyBYL9AtNHmnJxERaTLj7pnnzkbgC4GWXLMPVWu3m2aR3zMnuyOCMPLjWQffY5y-2FvyYGLXpqh-2BxoS5dZtWYvrxDkplKo4th2-2Fg4gIKlOB6vR0Iq55SnE7gjZ6E57uEFMVZnXrbp57sLNXoQzjGpD-2FgMJyMTApdypmOMIPkrQpzxJHY4HtE39hp0aMirozlHNkkQpMXIp-2FJ-2BqbED2A-3D&ref=fdaweb.com) was necessary due to what the agency described as “inadequate” company notification efforts to date.

“The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” CDRH director **Jeff Shuren** was quoted in a [release](https://www.fda.gov/news-events/press-announcements/fda-orders-philips-respironics-notify-patients-regarding-recall-certain-breathing-assistance?ref=fdaweb.com) as saying. “Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.”

Addressing the recall on the earnings call, van Houten said the repair and replacement program is underway globally and the company has produced more than 2.2 million repair kits and replacement devices to date. “We have increased our weekly production output more than threefold over recent months and are accelerating further despite the global supply chain challenges. We recorded a €65 million \[$70 million\] increase in the field action provision in the quarter which is mainly related to a higher expected volume of devices eligible for remediation and higher communication costs.”

van Houten said increased patient communications in U.S. have led to an estimated increase of 300,000 more units than originally projected will need to be remediated. “Given the increased number of devices, we now expect to complete over 90% of the production and shipment to customers in 2022,” he said. “Additionally, a further €100 million \[$106.4 million\] provision was recorded for potentially higher cost of execution, such as inflationary pressures and to ensure the speed of the program in a volatile environment as we strive to get a solution to patients as fast as possible.”

The company also has “strengthened management’s responsibility and oversight with organizational changes made in Sleep & Respiratory Care as well as in the Quality & Regulatory affair teams throughout 2021,” he continued. “These teams are laser focused on resolving this legacy issue whilst ensuring airtight procedures are in place for the future. We have also bolstered staffing and expertise around post-market surveillance, medical affairs, biocompatibility and toxicology within Philips.”

The ventilator recall has led the company to use it as a “pivotal moment to reinforce the focus on patient safety across the company and to cross-check learnings from the sleep \[apnea device\] recall, where relevant, across the enterprise,” van Houten said on the call. “We have also further stepped up scrutiny and have relooked at past severe incidents and are reviewing all products and complaints which has not led to the discovery of additional significant quality issues over the ones already announced earlier.”

“Last quarter,” he continued,” I mentioned that we recorded a provision in relation to two voluntary recalls in smaller business lines in the Connected Care portfolio with a well-defined scope. Both field actions are under execution in alignment with customers and regulators globally since earlier in the year. Importantly, we continue to engage and work closely with regulators globally, including the FDA, to clarify and follow up on the inspectional findings and requests in the Form 483.”

FDA late last year inspected Philips Respironics and issued the [29-page Form FDA-483](https://www.fda.gov/media/154099/download?utm%5Fmedium=email&utm%5Fsource=govdelivery). The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ sound abatement foam ([see story](https://www.fdaweb.com/fda-hits-philips-with-29-page-483-over-recalled-device/)).