Nationwide ResMed Shortage Due to Philips Recall

Q: What is a Voluntary Recall?

Well, this may come as a surprise, but any recall you see is likely voluntary by nature. It is only in very rare instances that the FDA must step in due to gross negligence on the manufacturer’s behalf to issue a (non-voluntary) recall. To <a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices#:~:text=Administration%20(FDA).-,Recall%20is%20a%20voluntary%20action%20that%20takes%20place%20because%20manufacturers,deception%20or%20are%20otherwise%20defective.&text=Recall%20does%20not%20include%20market%20withdrawal%20or%20a%20stock%20recovery." target="_blank" aria-label=" (opens in a new tab)" rel="noreferrer noopener" class="rank-math-link">quote the FDA on the matter: “Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.” So, to be clear — the “voluntary” part of the recall only refers to the manufacturer. Not to you. Meaning, it is not them saying, “Hey, customer, you can choose whether or not to have your device recalled.” Sorry to say, but this means they’re covering their own butts.

August 11, 2021
3:01 pm

Some time has passed since we first shared news of Philips Respironics’ voluntary recall of all DreamStation and DreamStation Go CPAP machines, and we want to ensure that you continue to have the most up-to-date information so that you can make an informed decision about moving forward with your CPAP therapy.

Allow us to give a quick summary of what’s going on as we’ve seen some confusion floating around the world wide web:

What is involved in the Philips Respironics Recall?

On June 14, 2021, Philips issued a voluntary recall notification for the United States for specifically affected ventilation and sleep apnea devices. The notification informs patients, users, and customers of potential impacts on patient health and clinical use related to this issue.

Possible health risks include exposure to degraded sound abatement foam, for example, caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.

What is a Voluntary Recall?

Well, this may come as a surprise, but any recall you see is likely voluntary by nature. It is only in very rare instances that the FDA must step in due to gross negligence on the manufacturer’s behalf to issue a (non-voluntary) recall.

To quote the FDA on the matter:

“Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.”

So, to be clear — the “voluntary” part of the recall only refers to the manufacturer. Not to you. Meaning, it is not them saying, “Hey, customer, you can choose whether or not to have your device recalled.” Sorry to say, but this means they’re covering their own butts.

Should I stop using my Philips Dreamstation or other recalled CPAP devices?

Yes, stop use of any Philips Respironics BiLevel PAP & CPAP sleep apnea devices. Then, consult with your physician to determine the benefits of continuing therapy and potential risks

If you don’t have a current physician, we are a team of Board Certified Sleep Specialists ready to help you get through the recall and continue your Sleep Apnea journey. Contact us anytime with any questions, or Live Chat with us directly on the website.

What are my options if I have a recalled Philips product?

We know this is a huge bummer, but you will need a replacement CPAP machine in order to continue your CPAP therapy safely. However, due to the recall, other manufacturers are left scrambling to outfit patients with safe CPAP, APAP, and BiPAP machines. Which brings us to…

Is there a nationwide ResMed shortage due to the Philips Recall?

The largest and most well-known CPAP manufacturer on the market, ResMed, has done a truly commendable job of trying to fill this huge gap left by the Philips recall. Unfortunately, they have reached their capacity and have announced that all machines will be going on backorder, including AirSense, AirCurve and AirMini.

While we trust that ResMed is working at mach speed to fulfill this absolutely massive amount of demand, we encourage you to order your CPAP machine replacement as soon as possible to ensure that you are “first in line” when orders begin to be fulfilled. The longer you wait to place your order, the further down on the list you’ll be, and thus, the longer you’ll wait to get your replacement machine.

AirSense™ 10 AutoSet™ Machine with HumidAir™

$883.00

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ResMed AirMini™ AutoSet Machine

$910.00

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AirCurve™ 10 S BiPAP Machine with HumidAir™

$1,776.00

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I have concerns about the Philips recall. Who can I talk to?

If you still have questions or concerns about the recall, or the backorder, we urge you to discuss them with your primary physician. As we mentioned above, we are also always available to help talk you through the issue, your options, and any lingering concerns.

Call us at 833-216-CPAP, email us at sleeptight@cpaprx.com, or live chat with our team right on the website.