Philips CPAP Recall

The FDA issued a Class I recall in 2023 for certain Philips CPAP and other respiratory devices — this is the most serious level of recall. It was issued after an earlier 2021 recall for specific models of Philips respiratory devices. Philips reworked and replaced many of the recalled breathing machines. But these also had problems.

The 2023 recall was designated as Class I due to the risk of respiratory failure, heart failure, severe injury or death from using the replacement machines. The 2023 recall covers the replacement devices.

Philips assigned incorrect or duplicate serial numbers to many of the reworked DreamStation devices during reprogramming, which means some may not provide therapy.

Philips Replacements and Financial Settlement 

In December 2023, Philips agreed to settle financial claims for defective machines for $479 million dollars. The settlement reimburses people who bought, rented, or leased certain machines in the U.S. between 2008 and 2021.

The settlement does not cover injuries or death caused by the machines. A separate multidistrict litigation covers those claims. As of December 2024, there were 821 individual Philips CPAP lawsuits in a Western Pennsylvania federal court.

In addition, Philips has sent out 2.46 million reworked CPAP replacement devices and repair kits, but the FDA says that the number of replacement devices is far fewer. Millions of people may have been affected by a Philips CPAP replacement shortage. If you’re waiting for a remediated device, please contact Philips for an update.

Not all models of Philips CPAP, BiPAP and ventilators are covered by the company’s breathing device recalls in 2021, 2022 and 2023. The recall mainly affects machines from the Philips DreamStation line.

In 2022, the FDA issued a Class 1 recall for magnetic CPAP and BiPAP masks. Using the masks could cause serious injury or death, and they can also interfere with metallic implants. More than 18 million units in the U.S. are impacted by the recall.

The further recalls in 2023 cover models of the Philips ventilation devices named in the 2021 recall and then reworked and sent out as replacement devices. These models were incorrectly programmed and could cause injury or death.

Each of the Philips CPAP, BiPAP and ventilator recalls were for different reasons.

From April 2021 to the 2023 recall, the FDA received over 105,000 medical device reports, including 385 death reports, linked to PE-PUR foam breakdown.

Potential Side Effects Related to the Recall

According to the U.S. Food and Drug Administration, potential side effects related to the use of the recalled equipment include asthma, dizziness, headache, hypersensitivity reaction such as an allergic reaction or another immune system reaction, inflammatory response, irritation to the airway, nausea or vomiting, and toxic or cancer-causing effects to organs.

“From a medical equipment perspective, I advise individuals who have experienced side effects to immediately stop using the recalled machine and seek alternative treatment options,” Mike Breslin, owner of ProMed Durable Medical Equipment, told Drugwatch. “But first consulting with health care providers is essential for appropriate guidance and support.”

In January 2024, U.S. Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) requested the U.S. Government Accountability Office (GAO) to investigate the FDA’s oversight of medical device recalls. This followed reports of the Agency’s failure to issue warnings about replacement Philips CPAP machines.

The investigation aims to shed light on the matter and ensure that the FDA remains accountable for its actions.

Device Events CEO and former FDA analyst Madris Kinard said the FDA should do more to ensure device safety before being marketed and sold, according to ProPublica. Currently, the FDA allows device makers to win clearance for a new product simply by showing that it’s substantially equal to an existing one already on the market.

Check the Philips website to see if the recall affects your breathing device and register it for remediation. You can manage the process via the Philips Patient Portal or by calling 877-907-7508.

For details on how to remediate your Philips CPAP, BiPAP or ventilator device, check the Philips website for specific instructions based on your device series. If you have any questions, visit the Voluntary Recall section of the site.

Consult your health care provider using a recalled Philips breathing machine for any health issues. They may suggest alternatives like lifestyle changes, nasal decongestants, weight loss or sleep apnea surgery.

Consider consulting a lawyer experienced in medical device lawsuits to determine if you have a claim against Philips for the recalled CPAP, BiPAP and ventilator machines.

Philips settled a class-action lawsuit for CPAP recall in 2023. However, settlements for cancer injury claims are still pending. There are 821 Philips CPAP lawsuits consolidated in a federal MDL in Pennsylvania.