CPAP Machine Recalls

Written by Natalie G., Writer

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In This Article

Our sleep expert will explain to you all about recalled CPAP machines, the possible risks if you use recalled CPAP machines, what to do if you are using it.

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Companies usually recall a product because of a manufacturer’s defect that makes it unsafe for many people.  Recalls happen for various products – cars, foods, toys, beds, and occasionally, CPAP machines. 

This was the case in June of 2021 when Philips Respironics announced a voluntary recall¹ of millions of its products, including CPAP machines, BiPAP machines, and ventilators. 

CPAPs recalled for health reasons could have adverse negative side effects, so if your device is recalled, it’s important to take proper action. In this article, we’ll go over the specifics of the Philips CPAP recall, including which products were recalled, why they were recalled, and what to do if you experience a CPAP recall with your device. 

What Types of Devices Have Been Recalled?

 The Philips CPAP recall included CPAP machines, BiPAP devices, and ventilators. Each of these machines is used to help those who have trouble breathing, either during sleep (like with sleep apnea) or while awake.  

• CPAP machines: A continuous positive airway pressure² machine is one of the most commonly prescribed treatments for sleep apnea. This machine provides a continuous stream of air pressure while you’re sleeping to prevent your airway from collapsing during sleep.² The air pressure should keep your oxygen levels steady throughout the night and prevent sleep apnea complications if used regularly.² 

• BiPAP devices: A BiPAP, or bilevel positive airway³ device, is similar to a CPAP machine in that it is often recommended for those with sleep apnea. Unlike a CPAP, which delivers one unchanging flow of air pressure, a BiPAP provides two different levels of air pressure: a higher level for inhaling and a lower level for exhaling.³ 

• Ventilators: A ventilator, or “breathing machine,” is used for conditions that make it difficult to breathe or get enough oxygen into your blood⁴ Ventilators are often used in a hospital setting but can also be used at home for certain chronic conditions.⁴ Unlike CPAP and BiPAP machines, which are only used during sleep, ventilators can also be used while you’re awake.⁴ 

Affected Recalled Devices

The reason the Philips CPAP recall included CPAPs, BiPAPs, and ventilators is that Philips included a particular piece of polyurethane foam in all of these devices in an attempt to reduce these machines’ noise levels.¹ Unfortunately, Philips found that this particular foam piece could break apart and then be ingested or inhaled⁵ by the user, which could result in several side effects. 

Additionally, polyurethane foam can cause harm by off-gassing certain chemicals, such as those found in some memory foam mattresses since they, too, use polyurethane foam.⁵ 

In the recall, Philips indicated that the products containing this foam should never be cleaned with ozone or UV cleaners.¹ The high heat or humidity in these cleaners might contribute to the degradation of the foam.⁵ The FDA also warns not to use UV or ozone cleaners⁶ on any CPAP devices.

In 2021 and 2022, Philips recalled and replaced⁷ certain CPAP, BiPAP, and ventilator machines. However, more recently in 2023, the FDA issued a Class I Recall⁸– their most serious type of recall – on certain Philips CPAP products. This more recent recall was issued after the FDA found some of Philips’ replacement machines were dangerous.⁷

Below is a list of the Philips products – CPAPs, BiPAPs, and ventilators – that have been recalled at this point.⁷

• Aeris
• A-Series BiPAP A30
• A-Series BiPAP A40 (ventilator)
• A-Series BiPAP Hybrid A30
• A-Series BiPAP V30 Auto (ventilator)
• C-Series ASV
• C-Series S/T and AVAPS
• Dorma 400, 500, Auto
• DreamStation ASV, Go, ST, Auto, and AVAPS
• DreamStation Auto
• E30
• FR REP DreamStation Auto BiPAP, DOM-RECRT
• Garbin Plus
• LifeVent
• OmniLab Advanced Plus
• REMstar SE Auto
• REP DreamStation Auto CPAP, DOM-RECERT
• REP DreamStation Auto CPAP Recert
• SystemOne ASV4, Q-Series, 50 series and 60 series
• Trilogy 100
• Trilogy 200
• Trilogy Evo ventilators

Additionally, in 2022 the FDA issued a recall on Philips CPAP and BiPAP magnetic masks, due to the risk of serious injury or death.⁷

More than 18 million units in the U.S. are impacted by this recall. The products include⁷: 

• Amara View Full Face Mask
• DreamWear Full Face Mask
• DreamWisp Nasal Mask
• Therapy Mask 3100 NC/SP
• Wisp and Wisp Youth Nasal Mask

Some users have filed lawsuits against Philips because they have been waiting years for replacements, and some who received a new device after the 2021 recall have since had their replacement devices recalled. 

As of September 2023, Philips has agreed to a $479 million CPAP settlement⁹ to compensate customers who bought these recalled devices. 

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Possible Health Risks of Using Recalled CPAP Machine

The Philips CPAP recall is being taken seriously because the side effects from ingesting or inhaling this particular foam can be severe. According to the FDA, these side effects may include¹: 

• Irritation to the eyes, skin, nose, and respiratory tract
• Inflammation
• Headache¹
• Toxic or cancer-causing effects
• Asthma
• Dizziness
• Hypersensitivity reaction (an allergic or other immune system response)¹
• Nausea or vomiting

As for the recalled magnetic CPAP and BiPAP masks, the FDA found that using the masks could cause severe injury or death and that the magnets in these masks could interfere with peoples’ metallic implants.⁷ 

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What to Do if You Are Using a Recalled Device

If you are using one of the above-mentioned products from Philips, or if you are using any breathing device that happens to be recalled in the future, the FDA has some recommendations. 

Recalled Ventilators

For those who are using a recalled ventilator, the FDA advises that you do not stop using the ventilator until you’ve talked to your healthcare provider since the risk of stopping the ventilator may be greater than the risk that the foam poses.¹ You might ask your doctor about using an inline bacterial filter, as these may help reduce exposure to the foam particles. However, it’s important to note that research is still ongoing on this.¹

You should also register your recalled device on the Philips’ recall website¹⁰ and talk to your doctor about any health issues you’re experiencing. You can report these health issues through the MedWatch Voluntary Reporting Form¹¹. 

Recalled CPAP and BiPAP Machines

If you are using one of the recalled CPAP and BiPAP machines listed above, the FDA recommends that you first talk to your doctor and see if they think your treatment should change in response to the recall.¹ Some doctors will recommend that you stop using the recalled device immediately and start using a different one as soon as possible, and other doctors may have you continue to use your recalled device if it is medically important until you can get a replacement.¹ 

Recall or not, you should never clean your device with any ozone or UV light cleaners.⁶ It’s also important to avoid removing the foam from the device yourself as this can ruin the CPAP or BiPAP’s effectiveness and increase your risk of exposure to the foam particles.¹ 

Because Philips has recently agreed to a settlement, you may be eligible to make a claim and receive compensation if you have been using one of these recalled products.

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How Do I Know if a Recalled Machine’s Replacement is Safe?

After several of Philips’ CPAP, BiPAP, and ventilator devices were recalled in 2021, Philips started replacing them with devices that did not include the same polyurethane foam. 

As mentioned, though, some of the replacement devices themselves were found to be unsafe and were also recalled. This is because Philips assigned incorrect or duplicate serial numbers to many of these replacement devices, meaning users could select the wrong factory setting or receive the wrong breathing support prescription.⁷ 

Other replacement items, including specific Trilogy Evo ventilators, were found to still contain some polyurethane foam and were recalled again.⁸ To find out if you received one of these ventilators, check for its serial number¹⁶.

Otherwise, the replacement CPAPs, BiPAPS, and ventilators that Philips sent out after their initial recall used a silicone-based foam rather than a polyurethane-based foam. The FDA is still trying to determine whether or not this foam is safe for users. However, at this time, they recommend that you continue to use these devices, and the FDA will communicate the results of their testing to the public as soon as they are available.¹ 

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Frequently Asked Questions