FDA Announces Recall of Certain Sleep and Respiratory Devices
Falls Church, VA, July 23, 2021 - The Food and Drug Administration (FDA) has directed Philips Respironics to recall millions of sleep and respiratory devices following concerns that foam in the devices, which is used to reduce sound and vibration, may break into particles and enter the air hose of the device and be inhaled by the user. In response, the Military Health System (MHS) has notified all TRICARE-authorized durable medical equipment providers of the recall. And it’s asking prescribing physicians to help notify patients of the recall and determine if they were issued a medical device on the Philips recall list.
Which devices does the recall affect?
The recall affects certain medical devices that were produced before April 26, 2021. They include:
Philips Constant Positive Airway Pressure (CPAP) devices
Bi-Level Airway Pressure (BiPAP) devices
Health care providers often prescribe these devices for home use to treat sleep apnea. The recall also includes some ventilators. However, military hospitals and clinics have begun taking separate actions to identify and defer use of the recalled ventilators.
What are the possible health risks of the CPAP and BiPAP devices?
The sound-reducing foam found in these medical devices may break into potentially harmful particles. These particles may enter the device’s air hose and cause the user to inhale them. If that happens, the user could experience mild to severe symptoms. These symptoms could be an inflammatory response, headache, irritation in the eyes or nose, respiratory issues, or possible toxic effects. The FDA is closely monitoring reports of adverse health effects. To date, there have been a small number of symptomatic complaints. But there have been no reports of death as a result of these issues.
What should you do if you own a recalled device?
You should check the Philips Respironics patient portal or call 1-877-907-7508 to see if your device is on the recall list. If so, make sure you register your device on the patient portal. Philips Respironics is working towards a solution to replace or repair all affected BiPAP or CPAP devices. Keep in mind, there could be some time before you receive a new device. So, it’s important to consider the risks and benefits of continued use of your current device while you wait. Be sure to talk to your provider if you have any concerns about continuing use of your device. Your provider can determine if the benefit of using the device outweighs the risk outlined in the recall.
If you continue to use your Philips device, the MHS recommends that you use it as prescribed. You should also clean it as described in the manufacturer’s owner’s manual. Don’t use products that contain ozone or ultra-violet light to clean, sanitize, or disinfect your device.
Do you have more questions about the recall? If so, be sure to contact the provider you received the device from. Philips Respironics is working to replace or repair affected devices. Go to the FDA website or Philips Respironics website to learn more.