After Hours: Behind the Giant CPAP Machine Recall (From the Archives)

Summary

Full Measure After Hours: Behind the Giant CPAP Machine Recall

Introduction

In the June 19, 2025 episode of Full Measure After Hours, host Sharyl Attkisson delves into the unprecedented safety recall of Philips Respironics' CPAP machines. This episode, titled "After Hours: Behind the Giant CPAP Machine Recall (From the Archives)," features investigative journalist Liz Mohan from ProPublica, who played a pivotal role in uncovering the depth of this major health concern.

Background of the CPAP Recall

Cheryl Akison opens the episode by setting the stage for one of the most significant medical device recalls in recent history. "In June of 2021, after discovering a potential health risk related to the foam used in some of these CPAP machines, Philips issued a voluntary recall," Akison explains (00:42). These Continuous Positive Airway Pressure (CPAP) machines are essential for millions suffering from sleep apnea, providing life-saving assistance by ensuring uninterrupted breathing during sleep.

Investigative Process

Liz Mohan elaborates on how ProPublica became involved in this investigation. "The topic of CPAPs came to me from the reporters who had already started this investigation," she states (02:13). Collaborating with the Pittsburgh Post Gazette, Mohan focused on the human impact behind the technical failures. She summarizes the story succinctly: "This is a story about patients and doctors who are impacted by the Philips Respironics recall of their CPAP machines... They withheld complaints from users who reported defects, and they withheld that information from the public" (03:01).

Human Impact: Patients and Doctors

The episode brings to light the personal toll of the recall through the story of the Stark family. Mohan describes them as a representation of the widespread fear among users: "They went on CPAP machines as soon as their doctor diagnosed them with sleep apnea... but all along they were doing the right things. And yet they're told your health might be harmed from using these machines" (05:51).

Additionally, the documentary highlights the chaos experienced by healthcare providers. Dr. Braden from Hillsboro, Oregon, recounts the tumultuous weeks following the recall, where "20,000 patients... were calling, asking for direction. But the doctors were caught in the middle too" (10:20). This unprecedented situation left both patients and medical professionals grappling with uncertainty and fear.

Company and Regulatory Response

Philips' response to the recall has been a point of contention. The company acknowledged receiving over 3,700 complaints over 11 years but only initiated an investigation nine years after the first report (05:04). Mohan points out the discrepancy in Philips' characterization of the complaints: "3700 complaints were over the span of 11 years. They were not all at once. And then they withheld them trickling in" (05:48).

Despite initial FDA and Philips agreements acknowledging potential risks—such as asthma and respiratory problems—Philips later downplayed these concerns. They claimed that the initial testing was based on a worst-case scenario and maintained the machines' safety. "We cannot say if people using these machines have gotten sick because of the machines," Mohan emphasizes (07:02).

Ongoing Concerns and Lessons Learned

The FDA has remained vigilant post-recall, especially concerning the newer DreamStation 2 CPAP machines. Recent reports indicate over 270 instances of thermal issues between August and November 2023, a significant increase from previous years. However, the FDA notes that these issues are not related to the foam used in the machines.

Mohan reflects on the broader implications of the recall: "Sleep isn't a luxury, it isn't optional. We all have a right to sleep... we don't know if the machine could harm you, but we're letting you make that decision" (08:36). The overarching lesson highlights the critical importance of transparency and timely communication in healthcare to safeguard patient well-being.

Conclusion and Further Resources

The episode concludes by directing listeners to ProPublica's documentary "With Every Breath" for an in-depth exploration of the CPAP recall. Cheryl Akison also provides updates on Philips' remediation efforts and the FDA's ongoing vigilance (11:55).

For those seeking more information, resources include:

• ProPublica Documentary: Search "With Every Breath" on ProPublica.org or through your preferred search engine.
• FDA Warnings: Detailed information on the FDA's stance and updates can be found at the official FDA website.
• Full Measure TV Program: Watch the full report on Full Measure via CherylAkison.com or FullMeasure.News.

Notable Quotes:

• "We don't know if the machine could harm you, but we're letting you make that decision." – Liz Mohan (08:36)
• "Sleep isn't a luxury, it isn't optional. We all have a right to sleep." – Dr. Carol Stark (09:19)
• "This was one of the most chaotic and disruptive recalls in medical history." – Liz Mohan (10:20)

Key Takeaways:

• The Philips CPAP recall affected millions, raising serious concerns about product safety and corporate responsibility.
• Delayed response to consumer complaints exacerbated the crisis, highlighting the need for better regulatory oversight.
• The human stories behind the recall underscore the profound impact on both patients and healthcare providers.
• Ongoing vigilance by regulatory bodies like the FDA remains crucial to prevent future health risks.

This comprehensive investigation by Liz Mohan and ProPublica sheds light on the complexities and repercussions of one of the most significant medical device recalls, emphasizing the importance of transparency, accountability, and the fundamental right to safe and effective healthcare solutions.

Transcript

[Cheryl Akison]

Hi everybody. Cheryl Achison here. I hope you enjoy this special from the Archives edition of Full Measure After Hours. Hi everybody. Cheryl Achison here. Welcome to another edition of Full Measure after hours. Today, ProPublica's Liz Mohan tells about the investigation into the unprecedented safety recall of America's most popular cpap machines. Sunday, April 14th on full measure, I'll be looking into a story that it seems should have made a lot bigger news. It's a huge recall of America's most popular CPAP machines. In June of 2021, after discovering a potential health risk that was related to the foam used in some of these CPAP machines, the company Philips issued a voluntary recall. Millions of people rely on these continuous positive airway pressure or CPAP machines to help them sleep better at night. Chances are you or someone you know uses or has used a CPAP machine. So when there was this huge safety recall of one brand, it raised a lot of questions and many of them are still open today. We are going to be hearing today from Liz Mohan who is a video journalist at the investigative nonprofit ProPublica. She's part of the team that covered this story. She helped make a short documentary that's called With Every Breath. Before we hear from her, you should know that in a statement, Phillips has said it does not agree with the characterizations in ProPublica's reporting on this topic. Phillips has said that the company's priority is patient safety and quality. Phillips has said that it regrets any distress and concern for patients, their families and care providers in this matter and deeply apologizes. Now here's ProPublica's Liz Mohan.

[Interviewer]

What got you into the topic of CPAPs?

[Liz Mohan]

The topic of CPAPs came to me from the reporters who had already started this investigation. And so this investigation was reported. This investigation was co reported by reporters at ProPublica and the Pittsburgh Post Gazette. And they approached me wanting to really bring out the human impact of the recall. While they were really focused on the science and on Phillips and what went wrong, they asked me to distill their findings into an emotional human and they asked me to distill their findings in a way that brought out the impact. Who are the patients and doctors affected?

[Interviewer]

If you had to tell the story like the front flap of a book in just a couple of sentences, how would you summarize what this to you is a story of?

[Liz Mohan]

This is a story about patients and doctors who are impacted by the Phillips Respironics recall of their CPAP machines and respiratory breathing devices for over 11 years. They withheld complaints from users who reported defects, and they withheld that information from the public.

[Interviewer]

If you can explain in really simple terms what a CPAP device does for people, they may have sort of a general idea, but not really know much about it.

[Liz Mohan]

A CPAP machine provides gentle air pressure to the user. Essentially, when you have sleep apnea, your throat muscles relax to such a degree that your airway collapses, and this can cause you to stop breathing, and it can signal to your body that an emergency is happening because oxygen is decreasing. So essentially, a CPAP machine just provides gentle air pressure through the nose or through the nose and mouth, and it keeps the airway open just enough to keep the user breathing smoothly all night.

[Interviewer]

What was the heart of the complaints about these CPAP machines?

[Liz Mohan]

The heart of the complaints were that users were finding black particles, specks, dust, and contamination in their machines. Even users who wash their machines every day, every other day, they saw these tiny black particles in the tubing of their machines, and they reported them.

[Interviewer]

The implication is they were breathing that stuff in.

[Liz Mohan]

Yeah. The implications. So the foam that was used in the machines is an industrial foam that is also found in sofas and mattresses. And at high heat, the foam can break down into these tiny disintegrated particles that are known to be toxic and potentially carcinogenic.

[Interviewer]

What was the company's response? Did you discover as part of the CO investigation that you did when they began to get these complaints from consumers?

[Liz Mohan]

Philips received over 3,700 complaints over the span of 11 years. And they first launched an investigation in 2019, which was nine years after the first complaint. And their response was that complaints leading up to the recall were few and far between and that they responded as soon as they understood the potential significance of the problem.

[Interviewer]

Did you find any evidence to the contrary?

[Liz Mohan]

No. Okay.

[Interviewer]

But 3700 doesn't seem like just a few.

[Liz Mohan]

Right. And these 3700 complaints were over the span of 11 years. They were not all at once. And then they withheld them trickling in.

[Interviewer]

Like a significant number.

[Liz Mohan]

Yes. Yes.

[Interviewer]

What's the story of the Starks who are featured in your video?

[Liz Mohan]

The Starks represent a couple who represent the fear of patients who are using this machine. So when I approached the documentary, I was thinking a lot about the crossroads that patients face. They have to make the decision to continue using a machine that down the road might harm them or stop using the machine and risk not sleeping, not having REM sleep, not healing as a process of sleep. And the Starks are a couple who did all the right things. They are in their 70s, they work out, they eat healthfully, they went on CPAP machines as soon as their doctor told them. They went on CPAP machines as soon as their doctor diagnosed them with sleep apnea. But all along they were doing the right things. And yet they're told your health might be harmed from using these machines. So they represent the fear.

[Interviewer]

What is the long term impact for people who did some people become sick right away or over these 11 years? And are other people at risk of becoming sick in the future even if they stop?

[Liz Mohan]

Yeah. At the time of the recall, the FDA and Phillips agreed that using these CPAP machines could lead to asthma, could lead to respiratory problems, could lead to potential toxic and cancer causing risks. But since the recall, Philips has walked back on those claims and they said that the initial testing was based on a worst case scenario outcome. And they maintain that the machines are still safe. And so we really cannot say if people using these machines have gotten sick because of the machines. We can only see that patients who use these machines got sick at the time of using the machines. Patients got sick and patients died while using these machines. But we cannot say for certain that that is linked.

[Interviewer]

Is there any toll of how many this happened to? Whether or not it's definitively linked? But how many people got sick and or died?

[Liz Mohan]

I can only say that millions of people use these machines and are impacted. We don't know to the degree, we cannot say because we cannot say for certain that someone was sick or died because of the machine. We can't say a number.

[Interviewer]

What would you say is the overarching lesson you learned as you found out more about this case, how it was handled by both the company, the government?

[Liz Mohan]

It was very apparent to me that sleep apnea is something that can happen to anyone. Sleep is something that I took for granted. And when I was approached to make this film, I thought about how do I make a film about sleep apnea, relate to anyone who sleeps? And Dr. Carol Stark said sleep isn't a luxury, it isn't optional. We all have a right to sleep. And so for these patients, I think about how they were not given a right to know sooner the risks of their machines if they had been told even a few years sooner. We don't know if the machine could harm you, but we're letting you make that decision.

[Interviewer]

Are there many competitors? Can people choose a different model or is this the largest maker and really.

[Liz Mohan]

The only go to Philips main competitor is ResMed and ResMed uses a different type of foam from Philips and they are the leading competitor along with Philips. When I was thinking about visualizing this film and I was tasked to how do you visualize sleep? How do you visualize these particles? When the FDA complaints said that patients found black particles, black shavings, dust and contamination, I was looking for metaphors in our natural world. So I filmed water droplets at night, I filmed water droplets coming out of a sprinkler to get at what these particles might look like just to get you in that headspace. I filmed fog, I filmed sunset, I filmed bed frames and pillows to try to just help people. Everyone sleeps. In addition to that, as important as it is to talk about the patients who were impacted by this recall, the doctors are also very much impacted. So when we were casting for this documentary, we were looking for a patient who was sick, which is Mark Edwards. And Mark Edwards has, Mark Edwards has pre existing conditions and a lot of people on sleep apnea have pre existing conditions. And if you have these pre existences, if you have pre existing conditions, you need a sleep AP machine even more to be able to heal, to be able to manage that. So Mark really shows someone who is sick and is potentially sicker because of this machine. The Starks represent the fear of will they find out tomorrow that they are harmed? And then to tie them all together is Dr. Braden in Hillsboro, Oregon, who described the chaos of in the weeks after the recall, 20,000 patients over the course of the time calling, asking for direction. But the doctors were caught in the middle too, because they wanted to provide answers to their patients. They wanted to clearly say this is when you'll get a replacement. This is how much it's harming you or not harming you. But they didn't know either. And so this was one of the most chaotic and disruptive recalls in medical history. And it affected patients and doctors to the extreme.

[Cheryl Akison]

If you'd like to see Liz Mohan and ProPublica's documentary With Every Breath, you can go to ProPublica.org and search with Every Breath. Or it's even easier just to go to your search engine and type in ProPublica and CPAP or ProPublica and with every Breath again. Phillips, for its part, has put out a statement saying the remediation of its sleep therapy devices is nearing completion, while the remediation of the affected ventilators separate issue is ongoing and that everyone at Philips is committed to achieving and maintaining the highest standards, building on a culture of integrity and compliance. There is a postscript to this, by the way. The Food and Drug Administration is warning patients and health care providers to carefully monitor the follow up to the problematic CPAP machines. The Philips Dream Station 2 CPAP machines for Signs of Overheating According to the FDA Quote the FDA recently received medical device reports associated with thermal issues such as fire, smoke, burns and other signs of overheating while people are using Philips DreamStation 2 CPAP machines. The FDA goes on to say the agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023 and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared to fewer than 30 the previous three years. So says the FDA, consumers should be aware that some DreamStation 2 CPAP machines were distributed as replacements for the recalled DreamStation 1 CPAP machines. And based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam that had been used in the machine. For more information on all of this, you can not only read the ProPublica investigation, but look at the FDA and what it says about it and visit usa.phillips.com Phillips spelled with one L in the middle I hope you catch full measure Sunday, April 14th to watch the full report on this matter, you can go to Cheryl Akkeson.com and click the Full Measure tab to see a list of stations and times. Or you can always just watch at FullMeasure News online on Sundays at about 9:31am Eastern Time. Then the program is posted at FullMeasure News thereafter around noon on Sunday. So if you happen to be listening to this after April 14th, you can watch a replay anytime at FullMeasure News. I hope you enjoyed today's podcast and that if you did, you'll leave a terrific review. Subscribe and share it with your friends. And be sure to check out my other podcast with original and fascinating topics. The Cheryl Akison Podcast. Now you can support independent journalism causes by visiting cherylakisson.com and clicking the Store tab for some thought provoking and fun products that are designed exclusively for independent and free thinkers like you and your family and friends. Proceeds benefit independent reporting causes like the ION Awards that I've started to encourage independent off narrative accurate news reporting. And you absolutely will not want to miss reading my new book. You can pre order it now. It's called Follow the How Big Pharma Misleads, Obscures and Prevails. There is stunning and instructive and helpful information in Follow the Science you can order it from the bookstore of your Choice or at HarperCollins or Amazon. Do your own research. Make up your own mind. Think for yourself.

[Liz Mohan]

It.