Philips: Respironics sleep-apnoea recall, FDA findings, consent decree, settlements and a DOJ agreement in principle
Philips: Respironics sleep-apnoea recall, FDA findings, consent decree, settlements and a DOJ agreement in principle: a public-record watch file compiled by Falling Shares Intelligence from filings and exchange disclosures, as of 2026-11-09. In June 2021 Philips Respironics recalled ventilators, CPAP and BiPAP machines over a sound-abatement foam that could degrade; the recall covered about 15 million devices worldwide.
From the June 2021 Respironics recall to a US consent decree, billion-dollar civil settlements and a November 2026 agreement in principle with the Department of Justice: what the record shows and what the company says.
Falling Shares Intelligence, Edited by Wung Thomas, Editor-in-Chief. As of .
Summary
- In June 2021 Philips Respironics recalled ventilators, CPAP and BiPAP machines over a sound-abatement foam that could degrade; the recall covered about 15 million devices worldwide.
- An FDA inspection in late 2021 recorded eight observations, including no documented analysis behind which products were recalled; in April 2024 a federal court entered a consent decree restricting new US sales from three Pennsylvania sites.
- Philips agreed to pay at least USD 479m for economic-loss claims (2023) and USD 1.075bn for personal-injury claims plus USD 25m for medical monitoring (2024), without admitting liability as reported.
- On 3 November 2026 Philips said it had reached an agreement in principle with the DOJ on criminal and civil investigations, with a EUR 288m provision; a state attorneys general investigation remains open.
Key figures
| DOJ provision, Q3 2026 | EUR 288m (Agreement in principle; payment expected Q1 2027; subject to documentation) |
|---|---|
| Personal-injury settlement | USD 1.075bn (Plus USD 25m for medical monitoring (April 2024)) |
| Economic-loss settlement | at least USD 479m (September 2023, subject to court approval at the time) |
| Devices recalled | about 15 million (Worldwide, per DOJ release) |
The recall and the FDA inspection
Voluntary recall of CPAP, BiPAP and ventilator devices
Philips Respironics recalled certain ventilators, CPAP and BiPAP machines in June 2021 because of potential health risks from the foam used to reduce sound and vibration, affecting about 15 million devices worldwide. The complaints in later litigation allege that the foam broke down and users inhaled or swallowed particles. (Jun 2021)
FDA inspection records eight observations
After an inspection of the Pennsylvania plant that ended on 9 November 2021, the FDA recorded eight observations. They included no documented investigation, risk analysis or failure-mode analysis supporting which foam-containing products were included in recalls; at least 14 known incidents or tests since 2016 without design changes or field actions; and a 2018 corrective action never formalised. (12 Nov 2021)
Consent decree and civil settlements
Consent decree restricts new US sleep and respiratory device sales
A federal court ordered Philips Respironics to stop manufacturing most sleep and respiratory devices at three Pennsylvania facilities and stop distributing them from those sites until stated requirements are met. Servicing of devices in use is permitted and Philips said it would continue remediation under the 2021 recall. (9 Apr 2024)
Economic-loss class settlement
Philips agreed to pay at least USD 479m to people who bought, rented or leased any of 20 affected breathing machine models. The deal covers economic losses only and excludes personal-injury and medical-monitoring claims. (Sep 2023)
Personal-injury and medical-monitoring settlement
Philips Respironics agreed to USD 1.075bn for personal-injury claims and USD 25m for medical monitoring, resolving claims in a multidistrict litigation in a Pennsylvania federal court that then included 762 pending CPAP cases. (29 Apr 2024)
Department of Justice and state investigations
Agreement in principle with the DOJ
Philips said it reached an agreement in principle with the US Department of Justice to resolve criminal and civil investigations related to the Respironics recall, recorded a EUR 288m provision in the third quarter, and expects payment in the first quarter of 2027, subject to finalising documentation. Its outlook excludes the investigation by the US state attorneys general. (3 Nov 2026)
Outcomes favourable to the company
Dutch court refuses investors' request for an inquiry
The Enterprise Chamber of the Amsterdam Court of Appeal denied requests from certain investors for an investigation into Philips' affairs related to the Respironics recall. (Q3 2026)
Decree entered without a liability finding
The DOJ said the claims resolved by the consent decree are allegations only and that there has been no determination of liability. (9 Apr 2024)
Standard
This file compiles regulator and court documents, exchange and SEC filings, company statements and published reporting about Koninklijke Philips N.V.. Allegations are attributed to those who made them. An investigation is not a charge, a charge is not a finding, and nothing here is a finding of wrongdoing unless a competent authority has made one. Philips has settled the civil claims described here without, as reported, admitting liability, and the consent decree and the pending DOJ agreement in principle are not determinations of liability. Individuals are not named unless an official document names them and they are central; otherwise roles are used. This is news coverage for information only, not investment advice.
Right of reply
Koninklijke Philips N.V., and anyone named in a record cited here, can send corrections or comments to info@fallingshares.com (or directly to the Editor-in-Chief, Wung Thomas, at wungthomas@fallingshares.com). Material responses will be published alongside the relevant entry.