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Recall alert: These medical devices could expose users to dangerous toxins

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There are all sorts of reasons you may not get a good night’s sleep, and sleep apnea can be one of them.

Just last month, Philips Respironics issued a huge recall of ventilators and continuous positive airway pressure machines (CPAP). This recall could leave millions of people with sleep apnea wondering how they’ll get a good night’s sleep. Read on for details on the recall and what you can do now.

Here’s the backstory

Philips Respironics recently issued a recall notice for some of its positive airway pressure (PAP) devices, including the DreamStation CPAP and BPAP machines. The recall is due to potential health risks from the foam used in these devices. The foam may degrade into particles that users could inhale.

The FDA has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries or death.

According to the manufacturer, the foam breakdown may be worsened by the use of unapproved cleaning methods, such as the “so clean machine” or other ozone cleaners. If you are currently using one of these devices, please stop immediately.

Details of the recall and the potential risks can be found on the manufacturer’s website here.

What are the risks and symptoms?

At the time of this recall, health risks were still being determined, and a full report is expected to be released soon.

Some reported symptoms include Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, upper airway irritation, cough, chest pressure and sinus infection.

Machines impacted by this recall

Here is the list of machines impacted by the recall globally:

What should you do next?

If you are using a life-sustaining mechanical ventilator device, it is recommended that you DO NOT discontinue or alter prescribed therapy without consulting your physician to determine appropriate next steps.

For patients on PAP (CPAP/BiPAP) devices, it’s recommended that you discontinue the use of affected units and consult with your physician to determine the benefits of continuing therapy and potential risks.

At the moment, Philips does not yet have a timeline of when repairs will be made. The company plans to replace the foam but doesn’t yet have the approval to do that. For many patients, it isn’t easy to go out and get a new machine due to insurance complications.

For many insurance companies, patients are only authorized to buy a new CPAP machine every five years. Some doctors are advising patients not to stop the use of their machines unless the symptoms become very severe. But you should talk to your doctor ASAP if you use one of the affected machines.

If suggested by your doctor, other alternatives could be to use another machine that is not part of the recall. There are also alternative treatments for sleep apnea, such as positional therapy for oral appliances.

There are long-term ways to reduce the risk of sleep apnea, such as losing weight, avoiding alcohol, stopping smoking. For moderate to severe sleep apnea, your doctor might recommend surgical solutions.

How to get a new CPAP machine

Philips is creating a registration process that will allow you to look up your device’s serial number and begin a claim if the unit is affected. Your Durable medical equipment provider will be notifying Philips Respironics that you require a replacement device. However, you may also register your device as a patient on this website directly.

You should register your device as soon as possible. The manufacturer’s website provides current information on the status of the recall notification and how to receive permanent corrective action.

Call 877-907-7508 if you cannot visit the website, need a Spanish translation, or do not have internet access.

You can also report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

Philips said that it’s moving as quickly as possible, but there are 3 to 4 million machines impacted by this, half of those in the U.S. The company also needs FDA approval for the fix.

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