CPAP Recall–Urgent Alert for CPAP, BiPAP and Ventilator Users

by | Jun 24, 2022 | Complete Health, General Dentistry, Sleep Apnea

If you suffer from a sleep disorder that requires a CPAP, BiPAP, or ventilator machine, you need to be aware of the latest news regarding the Philips Respironics sleep apnea machine recall. A recent story by NBC 5 has reported that Philips Respironics sleep apnea devices have been linked to 124 deaths and the company has enacted an extensive voluntary CPAP recall that will affect millions of individuals with sleep and airway disorders.

As a complete health dental practice, Sierra Smiles has a vested interest in helping protect the airway health of our patients. While it may seem like an unusual connection to see a dentist regarding sleep disorders, the fact remains that your oral and airway health are a part of sleep and a part of modern dentistry. At Sierra Smiles, an entire segment of our practice/treatment is dedicated to helping our patients get more sleep and higher quality sleep. This includes providing at-home sleep studies, treatment for disorders such as sleep apnea, and informing our patients of important news regarding issues like the recent recall.

Why Are the CPAP Machines and Other Devices Being Recalled?

In June of 2021, Philips began a massive recall due to concerns about materials in the machines potentially causing breathing issues. Philips machines manufactured over the last decade contain a polyester-based polyurethane foam that is meant to help make the devices perform quietly and minimize vibrations that can disrupt sleep. However, this sound-dampening foam has carcinogenic properties that are dangerous to patients. Per the Philips recall, this foam can break up and be breathed in by patients or swallowed during sleep. There is also a chance that hidden chemicals could be inhaled or ingested during sleep.

Philips notes that inhaling or swallowing the foam or associated chemicals could be hazardous to your health. It can cause long-term issues or even permanent damage. Philips also reports that patients using these machines in hot or humid regions could experience an increased negative effect. Patients who use ozone cleaners or other non-recommended cleaning methods are also more vulnerable to issues.

NBC 5 reported that the FDA suspects that 124 deaths have been connected to the use of these machines. More than 21,000 reports have been linked to the breakdown of the machines. The FDA has alerted the public that this recall is very serious and designated a Class One issue that must be addressed immediately by users. If you own one of the machines we have listed below, contact your doctor immediately.

Who Is Impacted by the Philips Respironics, CPAP, and PAP Recalls?

The impact of the Phillips Respironics machines is far-reaching. More than 15 million devices around the world could have this issue and there still is not much know about the long-term impact. The voluntary recall includes machines manufactured and sold between 2009 and April of 2021. We’ve included the list below, but it is important to check the FDA website for the latest information. In addition to the machines listed below, the FDA also reports that Trilogy Evo Ventilators sold between April and May of 2021 are also included in the list of recalled machines. Those machines must have a specific serial number. You can check here to learn more about that specific recall.

CPAP Recall Devices

  • A-Series BiPAP A30
  • A-Series BiPAP A40 (ventilator)
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 Auto (ventilator)
  • C-Series ASV (ventilator)
  • C-Series S/T and AVAPS
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • Dorma 400
  • Dorma 500
  • E30
  • Garbin Plus, Aeris, LifeVent (ventilator)
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q-Series)
  • Trilogy 100 (ventilator)
  • Trilogy 200 (ventilator)

Next Steps for Patients with Sleep Disorders

The FDA recommends that patients using these machines begin by speaking with their provider. It advises that patients do not stop using their machines without consulting a health care professional. This is very important. While patients are rightfully concerned about continuing to use recalled machines, it is critical that patients speak with their doctors before making a single change to their use of their machines. Patients should contact their doctor about adding a specialty filter to prevent potential issues while the recall is resolved or a suitable alternative is found.

Patients should register their devices here or call 1-877-907-7508. Depending on your health issues, you may be eligible for faster processing of a return. Your doctor may also advise you to cease using the machine or purchase a replacement without these issues.

Alternative Treatments for Sleep Apnea

The FDA has provided a list of alternatives to CPAP and other sleep apnea devices. In addition to positional therapy (sleeping upright or in a more structured position) or lifestyle changes (losing weight, quitting smoking, or vaping), the FDA also recommends oral airway appliances. As a complete health dentist, Sierra Smiles has offered these types of appliances to our patients with sleep-disordered breathing and witnessed excellent results. We provide our patients with kits to perform at-home sleep studies. This helps determine the right type of device for their individual disorder.

These devices are custom-fitted to alleviate potential discomfort and work with the exact shape of your mouth. Our patients report minimal to zero discomforts with these devices and a great deal of satisfaction with their results. Our alternative sleep appliances have been developed using the latest technology. They are non-invasive and achieve lasting results without wires, noise, or discomfort.

Be Informed and Sleep Safely

If you have a machine affected by the recent recall, give your primary care provider a call to discuss your next steps. If your provider has decided on alternative sleep aids such as oral devices, give us a call here at Sierra Smiles. We have options that can help treat many types of sleep disorders. If you are not affected by the recall but still experience exhaustion, irritability, and poor health due to a suspected sleep disorder, please contact us. We may be able to help you learn your options and rest easy once more.