Philips CPAP, Respironics & DreamStation Machines Recall

In June 2021, Philips Respironics announced that certain ventilators in the company’s CPAP and BiPAP range were being recalled due to health risks. The recalled ventilator machines are normally used by people suffering from sleep apnea. Philips Respironics CPAP and BiPAP machines contain a type of foam – polyester-based polyurethane – that can break down, releasing chemicals that can be harmful when inhaled or swallowed. In its comments on the recall, the FDA warned that “These issues could potentially result in serious injury, which can be life-threatening and require medical intervention to prevent serious injury.”

• October 1, 2024 - Philips Remediation progress update: Completing the Philips Respironics medical device recall remains our highest priority. With the remediation of the sleep therapy devices almost complete and remediation of the ventilators ongoing, it is important that patients, Durable Medical Equipment providers (DMEs) and clinicians are informed on the latest updates.
• August 1, 2024 - Philips Respironics Issues Update on Ventilator Alarm Failure
• July 1, 2024 - Philips BiPAP recall now linked to 65 deaths, 952 injuries
• June 1, 2024 - In wake of massive recall, SEC launches investigation into Philips Respironics.
• May 1, 2024 - Philips agrees to pay $1.1 billion settlement after wide-ranging CPAP machine recall.
• April 1, 2024 - How the Sleep Therapy Sector Is Responding to Philips Respironics' Exit.
• March 1, 2024 - FDA says 561 deaths tied to recalled Philips sleep apnea machines.
• February 14, 2024 - FDA Rejected Philips' Safety Claims After the CPAP recall but Delay in Alerting the Public.
• February 1, 2024 - Investigation raises new questions about Philips breathing devices after 2021 recall.
• January 1, 2024 - Millions of people used tainted breathing machines. The FDA failed to use its power to shield them.
• December 1, 2023 - FDA Cautions Public of Safety Issue with Philips' DreamStation 2 CPAP Machines.
• November 1, 2023 - Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines.
• June 1, 2023 - FDA RESPIRONICS, INC Premarket Notification
• May 1, 2023 - Philips Respironics recalls certain reworked DreamStation BiPAP and CPAP machines for the risk that they may deliver insufficient or inaccurate therapy.
• March 1, 2023 - UPDATE: Some Philips Respironics Ventilators and BiPAP Machines were Recalled due to potential health risks: FDA Safety Communication.
• February 1, 2023 - Recall Litigation Review: Year in Review – Philips CPAP/ BiPAP Still Under Fire
• January 1, 2023 - UPDATE: Some Philips Respironics Ventilators and BiPAP Machines were Recalled due to potential health risks: FDA Safety Communication
• FDA Says: Philips respirator recall reaches 260 reported deaths.
• November 16, 2022 - Philips Respironics recalls masks for BiPAP and CPAP machines due to safety issues.
• October 1, 2022 - The FDA announced that it is labeling another Philips Respironics recall as Class I, its most serious classification.
• September 1, 2022 - Certain Philips Respironics CPAP and BiPAP machines recalled due to a plastic issue.
• August 1, 2022 - Restless nights or sleep apnea patients with recalled CPAP machines.
• July 1, 2022 - Emails show that Philips knew of CPAP foam decay years before recall.
• June 8, 2022 - CPAP Litigation MDL 3014 update - Pretrial Order #17 (Doc. No. 605).
• June 1, 2022 - Philips Respironics voluntarily recalled certain ventilators (BiPAP or CPAP) machines due to potential health risks.
• May 1, 2022 - Philips issued voluntary recall notification safety notice for the BIPAP V60 ventilator product family.

The initial Philips CPAP recall occurred in June 2021. Almost a year later, the company was criticized by the FDA over how it handled the recall. 

On March 10th, 2022, the FDA issued a notification order to Philips, demanding that the company be proactive in contacting users of the CPAP and other ventilator machines to warn them of “unreasonable risk of substantial harm to public health.” The move by the FDA was influenced by the frustrations of patients and medical equipment suppliers who received inadequate information about the risks associated with Philips products. 

Philips CPAP recall lawsuits legal proceedings began in January 2022. A judge ordered that some of the faulty Philips CPAP machines be preserved as evidence for upcoming lawsuits. Philips CPAP recall lawyers are asking users of the equipment to come forward and join the lawsuit against Philips.

CPAP is an acronym for Continuous Positive Airway Pressure. CPAP machines are used by people who have difficulty breathing when sleeping. Some people who use CPAP machines have been diagnosed with a disorder called sleep apnea (although CPAP machines can be used for other reasons). While Philips is not the only medical device company that makes CPAP machines, specific devices in its product line have been deemed potentially dangerous. Millions of CPAP machines were recalled on June 14th, 2021.  The FDA classified the recall as Class 1, the most serious type of recall.

Philips makes a variety of ventilator machines, with a long list of them were found to be potentially dangerous. The following Philips ventilator machines have been recalled:

• A-Series BiPAP V30 Auto Ventilator
• C Series ASV, S/T, AVAPS
• Dorma 400, 500 CPAP
• DreamStation ASV
• DreamStation CPAP, Auto CPAP, BiPAP
• DreamStation GO CPAP, APAP
• DreamStation ST, AVAPS
• E30 (Emergency Use Authorization)
• Garbin Plus, Aeris, LifeVent Ventilator
• OmniLab Advanced Plus In-Lab Titration Device
• REMStar SE Auto CPAP
• SystemOne (Q series)
• SystemOne ASV4
• Trilogy 100 Ventilator
• Trilogy 200 Ventilator

Please note that Philips also recalled devices with specific serial numbers while not recalling the entire range.

The problem with Philips CPAP machines is related to the polyurethane foam contained within the devices. If this foam breaks down, it can cause black debris and invisible particles to enter the air pathways of the CPAP machines, eventually being inhaled by the person using the machine. Among the risks cited by medical experts are cancer and respiratory failure. Below we list some of the types of injury and symptoms linked to Philips CPAP ventilator machines:

• Cancer, including lung cancer, breast cancer, kidney cancer and brain cancer
• Respiratory diseases, including ARDS (Acute Respiratory Distress System)
• Liver disease
• Heart failure
• Inflammation of nose, throat, ears
• Renal (kidney) disease
• Headaches
• Irritation of the skin, especially around the eyes
• Cough and chest pressure

Please note that this list is not exhaustive. There have many dozens of Philips CPAP side-effects reported by those who have used the devices. If you are worried about the side effects of CPAP machines, you should contact your doctor.

Both Philips and the FDA have been publishing information about which Philips CPAP machines have been recalled, including details on specific serial numbers of affected Philips products.

At the time of writing, Philips has recalled all CPAP and BiLevel devices that were manufactured before April 26th, 2021. This includes all serial numbers of these models. Philips has also recalled seven types of mechanical ventilators (all serial numbers) manufactured before April 26th, 2021. 

Furthermore, the FDA has reported that three types of Trilogy EVO ventilators have been recalled.  These machines were distributed from March 15th, 2021 to May 24th, 2021. You can view the specific serial numbers on the FDA website. For further updates on which Philips ventilator machines are defective, check the FDA or Philips websites.

Is the Philips Resmed Airsense 10 recalled?

No. The Resmed Airsense 10 is not manufactured by Philips, and so it is not subject to the Philips ventilator recall.

Which Philips CPAP machines are being recalled?

Currently, the FDA lists 19 different Philips ventilator devices that are recalled, nearly all of which were manufactured before April 26^th 2021. These include popular models in the Dreamstation and Trilogy range.

How serious is the Philips CPAP recall?

The FDA has classified the Philips ventilator recall as a Class 1 recall. This is the most serious type of FDA recall, which is only used if there is potential for serious injury.

What are the symptoms of the Philips Respironics recall?

Those who have used defective Philips ventilator equipment have reported many different side effects and symptoms, including headaches, chest pains and breathing difficulties.

What is the status of Philips CPAP recall?

The Philips CPAP recall is currently ongoing. In March 2022, the FDA sent a notification order to Philips, urging it to do more to inform people about the potential danger of Philips ventilator machines affected by the recall.