Specialist article: Sleep
The Philips CPAP recallWhat is established and what you can do
In June 2021, Philips recalled millions of CPAP devices and ventilators, including the first DreamStation. Here you will find out what the problem with the foam was, which devices are affected, what the FDA and BfArM have established, where the recall stands today and what CPAP does for your airway.
Does this sound familiar?
A recall, and you sleep with the device every night?
What applies to you?
Tap whatever applies to you.
Then a calm look at the facts helps: what is established about the recall, what is not, what you can do and why the airway needs support at night in the first place.
Is my device affected?What I can do nowThe key points at a glance
- In June 2021, Philips recalled around 15 million CPAP, BiPAP and ventilation devices worldwide, including the first DreamStation. The reason was a sound-abating PE-PUR foam that can break down and release chemicals.
- The authorities later saw a low risk from the chemicals; for the particles, a risk could not be ruled out. According to Philips, 99 % of registered sleep therapy devices worldwide have now been processed.
- CPAP supports the airway from the outside, but it does not change the pattern. In our view, training breathing, swallowing and head balance addresses the cause and can create the conditions under which you may one day no longer need the mask. Until a follow-up measurement shows this, do not stop using any device on your own.
Video
The Philips recall and sleep apnoea therapy: putting it in context
Das Video lädt erst nach dem Klick. Dann werden Daten an YouTube (Google) übertragen.
The recall
Philips recall 2021: what happened
On 14 June 2021, Philips Respironics published a safety notice on several devices for sleep apnoea and ventilation. It became one of the largest recalls in medical technology.
Affected were CPAP devices, bi-level devices (BiPAP) and ventilators from the US manufacturer Philips Respironics. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) published the two safety notices on 22 June 202112. The cause lay inside the devices, in a foam intended to dampen the noise of the blower.
devices worldwide were affected by the recall, according to the US Food and Drug Administration (FDA)3
is the cut-off date. All devices of the listed models manufactured before this date are affected1
This is how the FDA classified the recall in July 2021, the most serious category in the USA3
For context, it is important to note that a component of certain devices was recalled, not positive airway pressure therapy as a method. Devices from other manufacturers were only affected if they were structurally identical to the Philips models5.
Device types
Philips DreamStation and others: which devices are affected
The safety notices list the models individually. The best known are the first-generation DreamStation and the SystemOne series.
CPAP and auto-CPAP
DreamStation, DreamStation Go, SystemOne (Q-Series), REMstar SE Auto, Dorma 400 and Dorma 5001.
Bi-level and ASV
DreamStation ASV, DreamStation ST and AVAPS, SystemOne ASV4, C-Series ASV, S/T and AVAPS, and the sleep laboratory device OmniLab Advanced+1.
Ventilators
Trilogy 100 and 200, Garbin Plus, Aeris, LifeVent, and BiPAP V30 and A30/A40. They support people with respiratory insufficiency2.
Structurally identical devices
Somnia 3 and 3i and Phönix 3 and 3i from Löwenstein Medical. According to the manufacturer, they are structurally identical to the SystemOne series and received their own safety information in summer 20215.
The DreamStation 2, the successor to the first DreamStation, is not affected. The statement by the European respiratory society, which was circulated in Germany by the German Respiratory Society (Deutsche Gesellschaft für Pneumologie), expressly points this out4.
The serial number tells you whether your own device is affected. Philips has set up a checking page for this, which you can reach via philips.com/src-update. It also explains where to find the number on your device.
CPAP foam
The foam in the CPAP device: two problems
The foam was located in the air path of the blower. So whatever happened to it could reach the air you breathe.
In the safety notice, Philips described two problems. First, the PE-PUR foam can break down into particles that enter the device’s air path and can be inhaled or swallowed. Second, it can release chemicals, known as volatile organic compounds, VOCs for short1. The particles are black and can become visible in the tube or mask. The gases cannot be seen.
Particles
- Form when the foam breaks down
- Can appear as black crumbs in the tube, humidifier or mask
- Possible consequences named: irritation of the skin, eyes and airways, inflammatory response, headache, asthma
- Heat, humidity and ozone cleaning promote the breakdown
Volatile chemicals
- Can be released as early as the first use
- Are not visible
- Possible consequences named: headache, dizziness, irritation, hypersensitivity, nausea
- Toxic and carcinogenic effects were also named as a possible risk
Both lists reflect the possible risks from the 2021 safety notice, not established harm. What the subsequent tests found is set out in the next section.
According to the manufacturer and the FDA, the breakdown is promoted by hot, humid environments and by cleaning devices using ozone, which Philips had not approved1. The FDA therefore advises against ozone and UV cleaners for these devices. In repaired devices, Philips replaced the foam with a silicone-based foam, for which the FDA also required independent testing9.
Context
How great was the risk? What the tests show
A safety notice does not in itself tell you how often harm actually occurs. Manufacturers and authorities investigated this in the years that followed.
In February 2022, the BfArM summarised the follow-up investigations on used DreamStation devices. No toxicologically relevant amounts of VOCs were found, and the institute assessed the risk of longer-term exposure as low. However, a risk from foam particles could not be ruled out. Up to that point, no incidents involving harm had been reported in Germany6.
were received by the FDA between April 2021 and September 2023 in connection with the foam breakdown, including 561 reports of deaths7
of foam breakdown or VOC release between April 2016 and January 2021 were listed in an FDA inspection report from November 2021, without an adequate risk analysis having followed10
The figure is often quoted as the number of confirmed deaths. It does not support that. The FDA itself stresses that neither the frequency nor the cause of an event can be derived from these reports. Reports can be incomplete, unverified or duplicated, and whether the device caused the event is not examined7.
A report is a suspicion, not proof.This applies in both directions. The reports do not prove harm, but they do not rule it out either.
Philips assesses its own tests on DreamStation, SystemOne and DreamStation Go devices as showing that exposure to VOCs and particles is not expected to cause appreciable harm to health11. The FDA considered the tests submitted up to October 2023 to be insufficient and required further testing8. For the foam in the Trilogy 100 and 200 ventilators, a different type of foam, a laboratory test for genetic damage produced an abnormal result. According to Philips, the assessment is still ongoing11.
Timeline
From the recall to today
The recall has occupied authorities, courts and suppliers for years. The most important milestones, as of 28 September 2026.
- 2015 to January 2021
Early indications
According to the FDA inspection report, the company had indications of degrading foam from 2015 onwards. An adequate risk analysis is not documented10.
- 14 June 2021
- July 2021
Class I in the USA
The FDA classifies the recall in the most serious category3.
- February 2022
- October 2023
FDA requires more tests
The authority considers the manufacturer’s testing to be insufficient8.
- April and May 2024
- July to September 2026
Status today
Philips reports that all steps of the US recall plan have been completed and that 99 % of registered sleep therapy devices worldwide have been processed. For the ventilators, replacements and testing are continuing12.
Affected?
Device affected? What you can do
Not every device was ever registered. You can find out whether yours is affected in a few steps.
Check the serial number
On the Philips checking page at philips.com/src-update, you enter the serial number and find out whether your device is affected.
Contact your supplier
In Germany, CPAP devices are usually provided by a medical aids supplier. They know whether your device has been replaced or repaired.
No ozone or UV cleaners
Such devices can further damage the foam. Clean the mask, tube and device as specified in the instructions for use9.
Watch out for particles
If you see black crumbs in the tube or mask, contact your supplier. The specialist societies name visible particles as a reason to consider a replacement4.
Keep your documents
Keep your correspondence with the manufacturer and supplier. This helps if questions about the replacement arise later.
You find out that your CPAP device is on the recall list. What do you do first?
Understanding CPAP
CPAP: what positive airway pressure therapy does
The recall has unsettled many people who sleep with a mask every night. That is why it is worth taking a look at the therapy itself.
CPAP stands for continuous positive airway pressure. The device blows air at slight positive pressure through the tube and mask into the airways and keeps the throat open during sleep.
In 1981, the Australian physician Colin Sullivan described the principle in five patients with severe sleep apnoea as a pneumatic splint, a splint made of air for the nasopharynx13. For moderate and severe sleep apnoea, CPAP is now the standard treatment.
As long as the device is running, the pressure prevents the throat from collapsing. At the same time, this is its limitation. The pressure comes from the outside and replaces the tension that the tongue, soft palate and throat wall would have to provide themselves. The control pattern that lets the airway give way at night remains unchanged. That is why CPAP is often needed for many years, and many people put the mask aside at some point.
of users used their CPAP device too little, measured against seven hours of sleep per night. This is shown by 82 studies from 20 years, with no improvement during this time. The authors therefore question the gold standard14
randomised, with 7,266 people with sleep apnoea: cardiovascular events and deaths were not demonstrably less frequent under positive airway pressure therapy. The authors see other benefits of the treatment15
A known side effect of positive pressure therapy is swallowing air. The pressure can direct air into the oesophagus and stomach, resulting in bloating and belching. Dr. Berndsen goes one step further and suspects that the control of breathing and swallowing in the brainstem adapts over years to pressure conditions that do not exist without the device. This has not yet been studied, and precisely for that reason, in our view, the question should be asked.
Like a crutch
If you have broken your leg, you are glad of the crutch. It helps carry the load while the leg cannot yet do so. But it does not train walking, and anyone who never puts weight on the leg again remains dependent on it. That is how we see CPAP. The positive pressure provides relief, but the body itself has to relearn the pattern that lets the airway give way.
Whether positive pressure therapy can later be reduced or discontinued is shown by a follow-up measurement in the sleep laboratory, and you make this decision together with your sleep medicine team. You can find more on masks, AHI and anti-snoring splints in the article Snoring and sleep apnoea.
The cause
Why the airway gives way at night
A recall draws attention to the device. The real question lies deeper: why does the airway need support at all?
In our view, the cause of obstructive sleep apnoea does not, as a rule, lie in a single tissue, but in the control pattern of the basic functions of breathing, swallowing and head balance. Muscles that are not integrated into their function are hardly used and lose tension. We call this functional hypotonia. During the day, this can be compensated for. During sleep, without voluntary control, the pattern prevails.
The pattern deviates
Mouth breathing, a low-lying tongue and a forward-shifted head balance replace the reference order. This often begins early, with a dummy, bottle or blocked nose.
The body compensates
The nervous system stores the compensatory movement as the preferred pattern. From then on, it runs without thinking.
The structure follows
Palate shape, tooth position and posture adapt over years. The tongue and pharyngeal wall lose tension.
Only then the symptom
Snoring, pauses in breathing, daytime tiredness. When and how severe depends on the extent of the disorder, the duration of compensation and age.
A key role is played by the genioglossus, the large tongue muscle that pulls the tongue forwards and keeps the space behind the base of the tongue open. In our view, whether it does its job depends on how the tongue is used in everyday life, with every swallow and in the tongue reference position on the palate.
This pattern is at the beginning of many causal chains. How mouth breathing changes the nose is described in the article on the nasal septum. What happens in the throat at night is explained in the article on snoring and sleep apnoea.
CPAP alternative
Is there an alternative to CPAP? Passive support and active training
Those affected by the recall have often wondered whether there is another way. The honest answer has two parts.
The recall has made louder a question that many people ask themselves anyway. The exposure was real. Anyone who used an affected device could inhale foam particles and off-gassing chemicals night after night, and whether and how much harm this caused has still not been conclusively clarified. All the more understandable is the wish not to depend on a mask for the rest of your life. In our view, this dependence is not fate.
Passive aids
- CPAP, mandibular advancement splint, positional pillow, nasal clip
- Change the geometry of the airway for the duration of use
- Work as long as they are used
- The control remains as it is
Active training
- Trains breathing, swallowing and head balance in the same sequence
- Addresses the control pattern
- Requires precise repetition over months
- Can be started alongside ongoing therapy
The two are not mutually exclusive. The passive support secures the night. The training works on the conditions under which the airway can become stable again through its own tension and the mask may one day become unnecessary. Whether that point has been reached is shown by a follow-up measurement.
Independent studies support the idea that the tension of the upper airways can be influenced by active training. A review from Stanford summarised nine studies with 120 adults. After exercises for the mouth, tongue and throat, the apnoea-hypopnoea index fell on average from 24.5 to 12.3 events per hour16. These studies do not examine the FaceFormer, but myofunctional exercises in general.
A Cochrane review from 2020 rates the evidence as being of low to moderate certainty. In the only study that compared training directly with CPAP, the index under training alone was higher than under positive airway pressure therapy17. That is not surprising. CPAP keeps the airway open mechanically for as long as it is running, and the studies only ran for two to four months. Training is meant to change the pattern, and that takes time.
The absence of a study does not mean that the connection does not exist. It means that it has not been tested.For the FaceFormer itself, only pilot observations without a control group are available so far in sleep apnoea. What exists and how to interpret it is set out on our studies page.
Training
Training the basic functions: alongside therapy
A breathing pattern does not change through insight, but through precise, frequent repetition.
In FaceFormer training you practise lip closure, nasal breathing, tongue alignment, swallowing and head balance at the same time, rather than individual muscles in isolation. The aim is for the basic functions to run on their own in their reference order again, even during sleep. More on this under How does FaceFormer therapy work?
In the basic exercise, the FaceFormer sits in the oral vestibule, behind the lips and in front of the teeth. The tip of your tongue rests on the palate behind the upper front teeth, you breathe through your nose, bite down briefly and swallow.
In the pull exercise, you pull on the FaceFormer while your lips hold against it. The animation shows what matters here: the head stays balanced over the body and tips neither forwards nor backwards.
At night you wear the FaceFormer ZERO once the basic exercise is established. The night is only a supplement, though. Anyone who uses it exclusively at night is using the FaceFormer as a passive support, and that is not what it is made for.
If you use CPAP at night, discuss with your sleep medicine specialists or a practice whether and when night-time use might be an option for you. Daytime training is independent of this and, provided there is no contraindication, can be started in parallel.
- From day 1
Basic exercise
Three times a day for a few minutes with the FaceFormer ZERO, guided by the free app.
- From around week 2 to 3
Pull exercise and night
The pull exercise is added. At night you wear the ZERO once you have mastered the basic exercise.
- After a few weeks
Switching to the ONE
During the day, you train with the FaceFormer ONE. It is the same size and shape as the ZERO, just made of firmer material.
- From around week 6
Breathing exercise
The breathing exercise combines the training with calm nasal breathing and breathing pauses that become longer over time.
- 6 to 12 months
Follow-up measurement
This is followed by maintenance training. A measurement in the sleep laboratory shows what has changed.
A pattern of breathing, swallowing and head balance does not change in a few weeks. The exercise manual expects six to twelve months until the new pattern runs by itself in everyday life and during sleep. You have to keep at it, and it can be worth it. How things continue with the device is something you decide with your sleep medicine team on the basis of your progress.
With obstructive sleep apnoea, you train alongside your ongoing treatment. You will find all modules on the exercise pages, and more on the timeline under Process and duration of FaceFormer therapy. We do not recommend taping your mouth shut at night. The reasons are explained in the article on mouth taping.
Questions
Frequently asked
Which Philips CPAP devices were recalled?
Among others, the DreamStation, DreamStation Go, SystemOne, REMstar SE Auto, Dorma 400 and 500, several bi-level and ASV devices, and the Trilogy 100 and 200 ventilators, manufactured before 26 April 2021. In addition, there are the structurally identical Somnia 3 and Phönix 3 from Löwenstein Medical. The serial number tells you whether your device is affected.
Why were the Philips devices recalled?
Because of a sound-abating foam made of polyester-based polyurethane, PE-PUR for short. It can break down into particles that enter the air path, and it can release volatile chemicals. Heat, humidity and ozone cleaners promote the breakdown.
Is the DreamStation 2 affected by the recall?
No. The first generation of the DreamStation is affected. The DreamStation 2 is not on the recall list, as the specialist societies for respiratory and ventilation medicine also point out.
Is the Philips recall complete?
For the sleep therapy devices, largely. According to Philips, 99 % of registered devices worldwide have been processed, and in July 2026 all steps of the US recall plan had been completed. For the ventilators, replacements and testing are still ongoing. In the USA, court-ordered conditions continue to apply to the sale of new devices.
Should I stop using my CPAP device if it is affected?
Not on your own initiative. The BfArM, the FDA and the specialist societies unanimously advise discussing any changes with the sleep medicine specialists treating you. Check the serial number, contact your supplier and ask about a replacement or repair.
Can the foam cause cancer?
In the 2021 safety notice, carcinogenic effects were named as a possible risk. Follow-up investigations found no toxicologically relevant amounts of the volatile chemicals in the DreamStation, and the BfArM assessed the risk as low. For the particles, a risk could not be ruled out, and the FDA required further testing. There is no evidence that the foam has caused cancer.
Is there an alternative to CPAP?
There are other passive aids such as the mandibular advancement splint or positional therapy. They change the geometry of the airway as long as they are used. In our view, the cause lies deeper, in the pattern of breathing, swallowing and head balance. This pattern can be trained, in parallel with ongoing therapy. Whether CPAP can later be reduced or discontinued is shown by a follow-up measurement.
Can I train with the FaceFormer alongside CPAP?
Yes, daytime training can be started alongside positive airway pressure therapy. You continue to use the device as prescribed. Whether and when you additionally wear the FaceFormer ZERO at night is something you discuss with your sleep medicine specialists or a practice. Changes are shown by a follow-up measurement in the sleep laboratory.
More articles from the knowledge section
Where to go next
Sources
- Philips Respironics (June 2021). Dringend: Sicherheitsmitteilung CPAP und Bi-Level PAP-Geräte. Schalldämmender Schaumstoff: Anfälligkeit für Zersetzung und Freisetzung flüchtiger organischer Verbindungen. Published by the BfArM on 22.06.2021, reference number 11652/21. Accessed on 28.09.2026. Source
- BfArM (22.06.2021). Dringende Sicherheitsinformation zu Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 und BiPAP A30/A40 Series von Philips Respironics, Inc. Reference number 11651/21. Accessed on 28.09.2026. Source
- U.S. Food and Drug Administration (as of 20.11.2024). Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. Accessed on 28.09.2026. Source
- Deutsche Gesellschaft für Pneumologie und Beatmungsmedizin (04.02.2022). Stellungnahme der European Respiratory Society für Patientinnen und Patienten sowie Mitarbeitende in der Pneumologie, Schlaf- und Intensivmedizin zum Rückruf der Firma Philips, Aktualisierung vom 01.02.2022. Accessed on 28.09.2026. Source
- Löwenstein Medical (July 2021). Sicherheitsinformation zum CPAP Phönix 3(i) und Somnia 3(i). Published by the BfArM on 02.08.2021, reference number 14098/21. Accessed on 28.09.2026. Source
- BfArM (updated 25.02.2022). Sicherheitskorrekturmaßnahmen zu ausgewählten Beatmungs- sowie CPAP- und BiPAP-Geräten von Philips Respironics, Empfehlungspapier der Fachgesellschaften. Accessed on 28.09.2026. Source
- U.S. Food and Drug Administration (as of 31.01.2024). Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. Accessed on 28.09.2026. Source
- U.S. Food and Drug Administration (as of 15.08.2024). Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. Accessed on 28.09.2026. Source
- U.S. Food and Drug Administration (as of 15.08.2024). Recommendations for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. Accessed on 28.09.2026. Source
- U.S. Food and Drug Administration (2021). Form FDA 483, Inspectional Observations, Philips Respironics, Inc., Murrysville, PA. Inspection from 26.08. to 09.11.2021. Observations by the inspectors, not a final decision by the authority. Accessed on 28.09.2026. Source
- Koninklijke Philips N.V. (continuously updated, accessed on 28.09.2026). Respironics field action information for Investor Relations: test results, settlements, consent decree. Manufacturer information. Source
- Philips Respironics (10.09.2026, data as of 01.09.2026). Remediation progress updates. Manufacturer information. Accessed on 28.09.2026. Source
- Sullivan CE, Issa FG, Berthon-Jones M, Eves L (1981). Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. The Lancet 1(8225):862-865. PMID 6112294. Source
- Rotenberg BW, Murariu D, Pang KP (2016). Trends in CPAP adherence over twenty years of data collection: a flattened curve. Journal of Otolaryngology – Head and Neck Surgery 45(1):43. PMID 27542595. Source
- Yu J, Zhou Z, McEvoy RD, Anderson CS, Rodgers A, Perkovic V, Neal B (2017). Association of Positive Airway Pressure With Cardiovascular Events and Death in Adults With Sleep Apnea: A Systematic Review and Meta-analysis. JAMA 318(2):156-166. PMID 28697252. Source
- Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA (2015). Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep 38(5):669-675. PMID 25348130. Source
- Rueda JR, Mugueta-Aguinaga I, Vilaró J, Rueda-Etxebarria M (2020). Myofunctional therapy (oropharyngeal exercises) for obstructive sleep apnoea. Cochrane Database of Systematic Reviews 11:CD013449. PMID 33141943. Source
Get started
Ready for the training?
The free FaceFormer app guides you through the basic exercises, counts along and reminds you of your sessions. If you wish, a practice from the practitioner directory can support you.
FaceFormer ZERO + ONE
Both material hardnesses for getting started, day and night. The set for adults.
FaceFormer ZERO
The softer FaceFormer for getting started, for children and for the night.
FaceFormer ZERO Children’s Set
ZERO with hygiene box, plush bag and success book with stamp.
FaceFormer training aims to restore the physiological setting of the basic functions of breathing, swallowing and head balance, with lip closure and the tongue reference position, thereby creating the conditions under which symptoms can improve. It does not replace a medical assessment. You can find practitioners near you in the practitioner directory.
