Case research · Sources checked October 1, 2026
Philips Respironics recalled CPAP, BiPAP and ventilator products MDL
Plaintiffs allege that the polyester-based polyurethane (PE-PUR) sound-abatement foam in the recalled devices can degrade into particles or off-gas volatile organic compounds that users inhale or ingest, causing injury. The complaints also claim Philips knew of foam problems before the June 2021 recall and made misrepresentations in marketing.
Every line on this page is checked against the court docket and the regulators involved. We do not decide whether you are part of this case or match you with a lawyer. What we do is help you get the medical records that matter, from any provider.
- Status
- Settlement
- Court
- U.S. District Court for the Western District of Pennsylvania
- Docket
- MDL No. 3014; master docket Misc. No. 2:21-mc-01230-JFC
- Judge
- Hon. Joy Flowers Conti (Senior U.S. District Judge)
- Started
- October 8, 2021
- Defendants
- Philips RS North America LLC (Philips Respironics), Philips North America LLC, Koninklijke Philips N.V. and 2 more
Where it stands
As of October 1, 2026
MDL 3014 remains pending before Judge Conti with 623 actions pending (1,033 total) per the JPML's October 1, 2026 report; new tag-along cases were still being transferred as of CTO-119 (June 22, 2026). The economic-loss class settlement received final approval April 25, 2024 (claims period ended August 9, 2024) and the medical-monitoring class settlement received final approval December 5, 2024. For personal-injury claims, a Master Settlement Agreement dated May 9, 2024 created a registration-based settlement program; plaintiffs who did not register ('Litigating Plaintiffs') are subject to the Docket Management Order, and an April 21, 2026 Scheduling Order sets general-causation expert and Rule 702 briefing through October 15, 2026, with non-compliant cases stayed.[2]
The complaint
What is alleged, and what is not decided
Plaintiffs allege that the polyester-based polyurethane (PE-PUR) sound-abatement foam in the recalled devices can degrade into particles or off-gas volatile organic compounds that users inhale or ingest, causing injury. The complaints also claim Philips knew of foam problems before the June 2021 recall and made misrepresentations in marketing. Claims include personal injury, medical monitoring, and economic-loss/consumer-protection class claims. Liability has not been adjudicated; the economic-loss and medical-monitoring class claims were resolved by court-approved settlements, and personal-injury claims proceed through a private settlement program and, for non-settling 'Litigating Plaintiffs,' continued MDL proceedings.
On the record
What the regulators and the court have said
- 01
FDA recall Z-1974-2021 (SystemOne, DreamStation, DreamStation Go, Dorma 400/500, REMstar SE Auto): Class 1, initiated June 14, 2021, posted July 13, 2021, status Open, Classified; reason: PE-PUR foam may degrade into particles that enter the air pathway and may off-gas certain chemicals; root cause 'Device Design'; 15,357,775 devices (10,307,186 U.S.).[12]
- 02
FDA reports receiving more than 116,000 medical device reports (MDRs) related to PE-PUR foam breakdown or suspected breakdown from April 1, 2021 through September 30, 2023, including 561 reports of death (page content current Jan. 31, 2024). MDRs are unverified reports and do not establish causation.[14]
- 03
FDA inspected Philips' Murrysville, PA facility Aug.–Nov. 2021 (Form 483 dated Nov. 9, 2021), issued a Section 518(a) notification order on March 10, 2022, and on April 9, 2024 a federal court entered a consent decree requiring a Recall Remediation Plan (new/remediated device or partial refund for certain devices), production/sale restrictions at PA and CA facilities until requirements are met, export limits, and independent expert review (page content current Nov. 20, 2024).[13]
Timeline
How the case has moved
Philips Respironics initiates recall of CPAP, BiPAP and ventilator devices for PE-PUR foam degradation (FDA recall Z-1974-2021 and related entries; 15,357,775 devices worldwide, 10,307,186 in the U.S.).[12]
FDA classifies the recall as Class I (most serious); classification dates July 13–15, 2021 across the recall entries.[13]
JPML centralizes 10 actions (104 related actions in 31 districts) in W.D. Pa. before Judge Joy Flowers Conti.[1]
Pretrial Order #1 organizes the MDL, stays discovery, orders preservation of evidence.[3]
FDA issues a Section 518(a) notification order requiring Philips to notify device users, suppliers and providers about the recall and health risks.[13]
Court approves publication of the Economic Loss class notice (settlement website www.RespironicsCPAP-ELSettlement.com; opt-out/objection deadline Feb. 7, 2024; fairness hearing Apr. 11, 2024; claims deadline Aug. 9, 2024).[4]
Federal district court enters consent decree against Philips Respironics requiring a Recall Remediation Plan, restrictions on new CPAP/BiPAP production at PA and CA facilities, and independent expert review of the replacement silicone foam testing.[13]
Final approval of the Economic Loss class settlement, final judgment and dismissal (Doc. 2736); Settlement Administrator Angeion Group; claims period ends Aug. 9, 2024.[5]
Docket Management Order (Doc. 2769) referencing the May 9, 2024 personal-injury Master Settlement Agreement (posted at RespironicsPISettlement.com) and setting preservation, record-production and expert-report obligations for non-registering Litigating Plaintiffs.[6]
Final approval of the Medical Monitoring class settlement (Doc. 3053), funding a Medical Advancement Program for research and education; personal-injury claims expressly excluded from the release.[7]
Scheduling Order (Doc. 4226) sets general-causation expert reports (May 22 and June 22, 2026), depositions (July 30, 2026), Rule 702 motions (Aug. 27, 2026), responses (Sept. 24) and replies (Oct. 15, 2026); cases of Litigating Plaintiffs not compliant by May 15, 2026 are stayed.[8]
JPML Conditional Transfer Order CTO-119 transfers another tag-along action; notes 347 actions added since the original 10.[10]
If this involves you
The records that matter, and who has them.
Whatever you decide to do next, you will be asked for these. They are yours by law, and most providers have up to 30 days to send them once they have your signed request.
Device identification: model and serial number (from the device label, DME delivery ticket, or Philips registration confirmation)
The recall covers specific models/serial ranges made before April 26, 2021; the Docket Management Order requires production of 'device usage records' and notice to anyone holding the device
Held by: Patient; durable medical equipment (DME) supplier; Philips (recall registration)
Prescription and sleep-study records (polysomnography, titration study, prescription for CPAP/BiPAP/ventilator)
Establishes why and when the device was prescribed and settings used; DMO requires notice to the prescribing provider
Held by: Sleep clinic / pulmonologist; prescribing physician
DME supplier records: delivery dates, model/serial, resupply history, compliance/usage downloads (SD card or cloud data)
Documents duration and intensity of exposure and which device was in use at which dates
Held by: DME supplier; device cloud data (e.g., manufacturer patient app)
Diagnostic records for the claimed injury (pathology, imaging, pulmonary function tests, oncology or ENT/pulmonary specialist notes)
The DMO requires medical records documenting the alleged diagnosis and injuries and expert reports addressing causation and alternative causes
Held by: Treating hospital; specialist practices; laboratories
Autopsy report and death certificate (death claims)
Expressly required by the Docket Management Order for death claims; preservation notice must go to pathologists/coroners
Held by: Medical examiner / coroner; state vital records
Records of ozone or other non-recommended cleaning devices used with the machine
FDA notes foam breakdown may be worsened by ozone cleaners; the economic-loss settlement assigned certain claims against ozone-cleaning companies
Held by: Patient (purchase records)
We send the request, follow up with the provider, and deliver the records to you. We don't take case details here and we never share your records with a law firm unless you tell us to.
Questions people ask
Straight answers, with sources
Is the Philips CPAP lawsuit real?
Yes. The JPML created MDL No. 3014 on October 8, 2021 and assigned it to Senior Judge Joy Flowers Conti in the Western District of Pennsylvania. As of the JPML's October 1, 2026 report, 623 actions remained pending in the MDL.[1]
Was the recall a real FDA Class I recall?
Yes. FDA's recall database lists the June 14, 2021 Philips Respironics recall entries (e.g., Z-1974-2021 covering DreamStation, SystemOne and related models) as Class 1 because the PE-PUR sound-abatement foam may degrade into particles or off-gas chemicals. FDA reports more than 116,000 related medical device reports through September 30, 2023.[12]
Have any settlements been approved?
Two class settlements have court approval: the Economic Loss settlement (final approval April 25, 2024; claims period ended August 9, 2024) and the Medical Monitoring settlement (final approval December 5, 2024), which funds research and education rather than individual payments. Personal-injury claims were not released by either settlement and are handled through a separate May 9, 2024 Master Settlement Agreement or continued litigation.[5]
What is happening with personal-injury cases now?
Plaintiffs who did not register for the private settlement program are 'Litigating Plaintiffs' who must comply with the May 9, 2024 Docket Management Order (preservation notices, medical records, device usage records and expert reports). An April 21, 2026 Scheduling Order sets general-causation expert and Rule 702 briefing through October 15, 2026 and stays cases of plaintiffs not compliant by May 15, 2026.[8]
What did the 2024 consent decree do?
On April 9, 2024 a federal court entered a consent decree requiring Philips Respironics to carry out a Recall Remediation Plan (replacement or remediated device, or a partial refund option for certain devices), restricting production and sale of new CPAP/BiPAP devices at several Pennsylvania and California facilities until requirements are met, and requiring independent expert review of the replacement foam testing and of other facilities.[13]
Sources
Where every fact on this page comes from
Primary sources only: court orders, the Judicial Panel on Multidistrict Litigation, federal regulators and state attorneys general. Each entry shows the day we opened it. This is reference material, not legal or medical advice.
- [1]MDL No. 3014 Transfer Order (Oct. 8, 2021)
JPML (hosted by W.D. Pa.) · pawd.uscourts.gov · opened October 12, 2026
Centralizes 10 actions before Judge Conti; summarizes PE-PUR foam allegations.
- [2]Philips Recalled CPAP, BI-LEVEL PAP, and Mechanical Ventilator Products Litigation, MDL No. 3014 (court MDL page)
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
Index of orders including settlement approvals, Docket Management Order, 2026 orders and CTO-119.
- [3]Pretrial Order #1 (Nov. 10, 2021)
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
Initial organization of the MDL, discovery stay and preservation.
- [4]Order granting motion to publish Economic Loss class notice (Doc. 2390) with attached notice
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
Dec. 12, 2023; notice lists settlement website, Feb. 7, 2024 opt-out/objection deadline, Apr. 11, 2024 fairness hearing and Aug. 9, 2024 claims deadline.
- [5]Order Granting Final Approval of Class Settlement Agreement and Release of Economic Loss Claims (Doc. 2736)
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
Apr. 25, 2024 final approval; claims period ends Aug. 9, 2024; personal-injury and medical-monitoring claims preserved.
- [6]Docket Management Order for Claims of Litigating Plaintiffs (Doc. 2769)
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
May 9, 2024; references the personal-injury Master Settlement Agreement and sets record and expert obligations for non-registering plaintiffs.
- [7]Order Granting Final Approval of Class Settlement Agreement and Release of Medical Monitoring Claims (Doc. 3053)
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
Dec. 5, 2024 final approval of Medical Advancement Program settlement; personal-injury claims excluded from release.
- [8]Scheduling Order (Doc. 4226)
U.S. District Court, W.D. Pa. · pawd.uscourts.gov · opened October 12, 2026
Apr. 21, 2026 general-causation and KPNV jurisdiction schedule through Oct. 15, 2026; stays non-compliant cases.
- [9]JPML Transfer Order, Gravelyn (Doc. 4201)
JPML (hosted by W.D. Pa.) · pawd.uscourts.gov · opened October 12, 2026
Apr. 6, 2026 transfer of a tag-along action over plaintiff's objection.
- [10]Conditional Transfer Order CTO-119 (Doc. 4264)
JPML (hosted by W.D. Pa.) · pawd.uscourts.gov · opened October 12, 2026
June 22, 2026; transfers Payne (E.D. Mo.); 347 actions added since the original 10.
- [11]Pending MDL Dockets by Actions Pending (Report Date 10/1/2026)
JPML · jpml.uscourts.gov · opened October 12, 2026
MDL 3014 pending in W.D. Pa. (Conti) with 623 actions pending, 1,033 total.
- [12]Medical Device Recall Z-1974-2021 (SystemOne, DreamStation, DreamStation Go, Dorma, REMstar SE Auto)
FDA (accessdata.fda.gov) via openFDA device/recall and device/enforcement · accessdata.fda.gov · opened October 12, 2026
Class 1 recall initiated June 14, 2021 for PE-PUR foam degradation; 15,357,775 devices.
- [13]FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
FDA · fda.gov · opened October 12, 2026
Timeline: Class I (July 2021), Form 483 (Nov. 9, 2021), 518(a) order (Mar. 10, 2022), consent decree entered Apr. 9, 2024 and its requirements.
- [14]Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
FDA · fda.gov · opened October 12, 2026
More than 116,000 MDRs and 561 reported deaths, Apr. 1, 2021–Sept. 30, 2023.
- [15]Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
FDA · fda.gov · opened October 12, 2026
Overview of recalled models (made 2009–Apr. 26, 2021) and the Apr. 9, 2024 consent decree.