Philips CPAP and Ventilator Recall Litigation: What the Record Shows

In June 2021 Philips Respironics recalled millions of CPAP, BiPAP and mechanical ventilator devices because the polyester-based polyurethane (PE-PUR) sound abatement foam could degrade and release particles or chemicals into the device air path. The FDA classified the action as a Class I recall, and federal lawsuits were consolidated in MDL No. 3014 in the Western District of Pennsylvania. In April 2024 a court entered a consent decree restricting new device sales from several Philips facilities, and later that month Philips announced a USD 1.1 billion resolution of the personal injury and medical monitoring litigation. No court in the records cited here has found that the devices caused any individual’s illness.

The recall and the FDA’s actions

On June 14, 2021 Philips issued a voluntary recall notification for certain Bi-Level PAP, CPAP and mechanical ventilator devices. The FDA published the announcement on June 15, 2021, alerted device users on June 30, 2021, and classified the recall as Class I in July 2021 (FDA).

The FDA describes the problem as PE-PUR sound abatement foam breaking down into particles or chemicals that could be breathed in or swallowed; heat, humidity and ozone cleaners may worsen it (FDA).

Later actions include a March 10, 2022 notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act, after the agency found Philips’ notification efforts inadequate; a May 2, 2022 proposal under section 518(b) for a repair, replacement or refund plan for devices made after November 2015; and an October 5, 2023 statement that the FDA “remains unsatisfied with the status of this recall” and did not believe Philips’ testing was adequate. The FDA also asked Philips to retain an independent laboratory to test the silicone-based foam used in reworked devices, after an inspection found a similar device sold abroad failed a test for volatile organic compound release (FDA).

The consent decree

The Department of Justice filed a complaint on April 4, 2024 alleging that Philips Respironics made and distributed adulterated and misbranded devices in violation of the Federal Food, Drug, and Cosmetic Act. On April 9, 2024 Judge Robert J. Colville entered a consent decree of permanent injunction against Philips RS North America LLC, Respironics California LLC, Philips Holding USA Inc. and several individual defendants including Roy Jakobs, chief executive of Royal Philips (DOJ).

The decree restricts, with limited exceptions, new production and sales of CPAP and BiPAP machines and other devices at several Philips facilities in Pennsylvania and California until the company completes the repair, rework, replacement and refund steps in a Recall Remediation Plan agreed with the FDA and complies with manufacturing and reporting requirements, needing written FDA notice before resuming. It also bars exporting remediation units for commercial distribution unless US patients are served first, and requires independent review of the silicone foam testing (DOJ).

What is established vs. what is alleged

Established by agency records and court orders:

• The devices were recalled in June 2021 over potential health risks; the FDA classified the recall as Class I, covering about 15 million devices worldwide (FDA; DOJ).
• A federal court entered a consent decree of permanent injunction on April 9, 2024 (DOJ).
• The MDL court granted final approval to an economic loss class settlement on April 25, 2024 and to a medical monitoring class settlement on December 5, 2024 (court orders).
• Philips announced a USD 1.1 billion resolution on April 29, 2024 (Philips).

Alleged, not decided:

• That the recalled devices caused any specific injury. Philips stated that it does not admit fault or liability, or that any injuries were caused by its devices.
• That Philips violated the Federal Food, Drug, and Cosmetic Act. The DOJ described the resolved claims as allegations only, with no determination of liability.

Where the claims stand procedurally

The federal cases are consolidated in In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation, MDL No. 3014, in the Western District of Pennsylvania (Master Docket Misc. No. 21-1230), assigned to Judge Joy Flowers Conti. The JPML issued the transfer order on October 8, 2021, moving 10 actions and noting 104 related actions in 31 districts (JPML).

Three resolutions moved on different tracks:

• Economic loss claims: final approval on April 25, 2024, after an April 11 fairness hearing (court order).
• Medical monitoring claims: final approval on December 5, 2024; that order preserved individual medical monitoring, economic loss and personal injury claims (court order).
• Personal injury claims: Philips announced on April 29, 2024 an agreement, reached through mediation before retired Judge Diane M. Welsh, resolving the personal injury litigation and the medical monitoring class action for a capped USD 1.1 billion; Philips said it does not admit fault or liability (Philips).

The MDL remains active: Conditional Transfer Order 119 transferred a tag-along action on June 22, 2026, and the JPML noted 347 further transfers since 2021 (JPML).

Key dates

• July 2021: the FDA classifies the recall as Class I (FDA).
• October 8, 2021: the JPML creates MDL No. 3014 (JPML).
• March 10, 2022: the FDA issues a section 518(a) notification order (FDA).
• January 29, 2024: Philips announces agreement on the consent decree terms (Philips).
• April 9, 2024: the court enters the consent decree (DOJ).
• April 25, 2024: final approval of the economic loss class settlement (court order).
• April 29, 2024: Philips announces the USD 1.1 billion resolution (Philips).
• December 5, 2024: final approval of the medical monitoring class settlement (court order).
• June 22, 2026: CTO-119 transfers another tag-along action to MDL 3014 (JPML).

What this does not establish

• That the devices caused any individual’s injury. Philips expressly denied admitting that, and these records contain no liability finding.
• How much any individual claimant will receive. The USD 1.1 billion is a capped total announced by the company, allocated by plaintiffs’ leadership and a settlement administrator.
• That new device sales have resumed. The decree conditions resumption on FDA compliance and completed remediation.
• That the FDA’s questions about the silicone-based foam in repaired devices are settled; that foam remains subject to independent testing.

Frequently asked questions

Is there a Philips CPAP settlement, and is it final?

Three tracks differ. The MDL court gave final approval to the economic loss and medical monitoring class settlements in April and December 2024. The personal injury resolution, announced after mediation, is not a class settlement; Philips said it does not admit fault or liability.

Who is covered by MDL 3014?

It covers federal lawsuits over the recalled devices, including individual personal injury claims and putative consumer class actions (JPML).

What does the consent decree require of Philips?

It bars new production and sales of CPAP and BiPAP machines and other devices at several Philips facilities in Pennsylvania and California until the company meets manufacturing, reporting and remediation requirements, and it requires a Recall Remediation Plan offering a new or reworked device or a refund for certain models (DOJ).

What should a device user do?

The FDA advises following the manufacturer’s cleaning instructions, avoiding ozone and ultraviolet cleaners, registering the device with Philips, and reporting problems through MedWatch. It also says that discontinuing use of a repaired device may be more harmful than continuing it (FDA). Anyone weighing their own legal position should consult a lawyer licensed in their state.

CollectiveClaim.us covers this case under medical device litigation. Related reading: the hernia mesh litigation, the NEC infant formula litigation, MDL vs. class action, and how mass tort litigation works.

Sources

1. U.S. Food and Drug Administration: “FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines” (link, accessed 2026-10-13)
2. U.S. Food and Drug Administration: “CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam” (link, accessed 2026-10-13)
3. U.S. Department of Justice: “Court Enjoins Philips Respironics from Manufacturing and Distributing Adulterated and Misbranded Sleep and Respiratory Devices at or from Three Pennsylvania Facilities” (link, accessed 2026-10-13)
4. U.S. Judicial Panel on Multidistrict Litigation: “MDL No. 3014: Transfer Order” (link, accessed 2026-10-13)
5. U.S. Judicial Panel on Multidistrict Litigation: “MDL No. 3014: Conditional Transfer Order CTO-119” (link, accessed 2026-10-13)
6. U.S. District Court (W.D. Pa.): “Order Granting Final Approval of Class Settlement Agreement and Release of Economic Loss Claims” (link, accessed 2026-10-13)
7. U.S. District Court (W.D. Pa.): “Order Granting Final Approval of Class Settlement Agreement and Release of Medical Monitoring Claims” (link, accessed 2026-10-13)
8. Royal Philips: “Philips announces its 2024 First Quarter Results” (link, accessed 2026-10-13)
9. Royal Philips: “Philips Respironics reaches agreement with US government on a consent decree creating a clear path forward” (link, accessed 2026-10-13)

CollectiveClaim.us publishes general legal information. This article is not legal advice and does not create an attorney–client relationship. Court records and agency actions change; verify current status with the court or agency before relying on it.