An official website of the United States government
Here's how you know
A .mil website belongs to an official U.S. Department of Defense organization in the United States.
A lock (lock ) or https:// means you’ve safely connected to the .mil website. Share sensitive information only on official, secure websites.

News | July 23, 2021

FDA Announces Recall of Certain Sleep and Respiratory Devices

By TRICARE Communications

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.
Health care provider reviews a notebook

Know the Difference: TRICARE Network Provider vs...

News
Nov. 22, 2022

Are you looking for a new doctor? Finding the right doctor is crucial to your overall health. Regular checkups...
Read More
Two service members stand with two children

Keeping Your DEERS Info Current

News
Nov. 17, 2022

TRICARE Open Season is the time to make changes to your TRICARE health care coverage for the upcoming year...
Read More
Blood Donor Eligibility Update

"Mad Cow" Blood Donor Ban Lifted

News
Nov. 17, 2022

A decades-old blood donor ban was recently lifted by the Food and Drug Administrationmad cow, potentially...
Read More
Staff assigned to Naval Hospital Bremerton's OB-GYN clinic display a number of the instruments and devices associated with patient-centered care during the walk-in contraceptive clinic, an essential part of women's health services provided at NHB. The Defense Health Agency recently issued an Administrative Instruction for access to walk-in contraception services across the Military Health System, letting beneficiaries discuss and receive their preferred and medically appropriate care.

Walk-in Contraceptive Services Required at Hospi...

News
Nov. 15, 2022

The Defense Health Agency is expanding walk-in contraceptive care services to improve reproductive health...
Read More
Service member poses with her spouse

TRICARE Open Season is Here: Find Right TRICARE ...

News
Nov. 14, 2022

TRICARE Open Season begins today, Nov. 14. For most TRICARE beneficiaries, this is your chance to enroll in a...
Read More
A smiling baby

What You Should Know About RSV: Symptoms, Preven...

News
Nov. 09, 2022

You may have heard of a virus called respiratory syncytial virus, also known as RSV. TRICARE encourages you to...
Read More
Service member hugs family

Preview 2023 TRICARE Health Plan Costs

News
Nov. 07, 2022

Every year, TRICARE costs may change based on the law, the federal cost of living adjustment, changes in the...
Read More
A graphic promoting the Nov. 17 TRICARE Webinar

TRICARE to Host Open Season Webinar on November 17

News
Nov. 04, 2022

Don’t miss the “TRICARE Open Season and Your Options” webinar on Nov. 17 at 1 p.m. ET to learn more about this...
Read More

Nov. 22, 2022

Know the Difference: TRICARE Network Provider vs. Non-Network Provider

Are you looking for a new doctor? Finding the right doctor is crucial to your overall health. Regular checkups are one of the best ways to screen for diseases and prevent future health problems. When searching for a doctor, you may come across the term “network provider” or “non-network provider.” Understanding these two provider types matters to you and your family.

Nov. 17, 2022

Keeping Your DEERS Info Current

TRICARE Open Season is the time to make changes to your TRICARE health care coverage for the upcoming year. But is your information still current in the Defense Enrollment Eligibility Reporting System (DEERS)? If you’re unsure, now is a good time to check.

Nov. 17, 2022

"Mad Cow" Blood Donor Ban Lifted

A decades-old blood donor ban was recently lifted by the Food and Drug Administrationmad cow, potentially increasing the nation's blood supply by hundreds of thousands of donors each year.

Nov. 15, 2022

Walk-in Contraceptive Services Required at Hospitals and Clinics

The Defense Health Agency is expanding walk-in contraceptive care services to improve reproductive health services. These services include same-day access with no appointment or referral needed.

Nov. 14, 2022

TRICARE Open Season is Here: Find Right TRICARE Plan for You

TRICARE Open Season begins today, Nov. 14. For most TRICARE beneficiaries, this is your chance to enroll in a health plan or change health plans for coverage that starts Jan. 1, 2023. You have until Tuesday, Dec. 13, to make those changes.

Nov. 9, 2022

What You Should Know About RSV: Symptoms, Prevention, Care

You may have heard of a virus called respiratory syncytial virus, also known as RSV. TRICARE encourages you to be familiar with the signs of RSV and see your health care provider if you think you or a family member has RSV.

Nov. 7, 2022

Preview 2023 TRICARE Health Plan Costs

Every year, TRICARE costs may change based on the law, the federal cost of living adjustment, changes in the cost of health care services and prescription drugs, and other factors. Depending on your TRICARE plan, you may see changes to your costs, including enrollment fees, premiums, cost-shares, and copayments next year.

Nov. 4, 2022

TRICARE to Host Open Season Webinar on November 17

Don’t miss the “TRICARE Open Season and Your Options” webinar on Nov. 17 at 1 p.m. ET to learn more about this year’s TRICARE Open Season.

Nov. 1, 2022

Q&A: Learn About Changes to Specialty Drugs Filled in the TRICARE Pharmacy Network

Starting Jan. 1, Accredo will be the primary in-network pharmacy to fill specialty drugs in the TRICARE pharmacy network. If you’re currently filling your specialty drugs at a retail network pharmacy, you can move your specialty drugs to Accredo now to avoid disruptions to your medication therapy.

Oct. 25, 2022

Have Low Back Pain? You May Qualify for TRICARE Demonstration

There are many reasons to go to the doctor, but a very common reason is pain. Chronic pain—pain lasting three or more months—affects thousands of service members and their families every day. One such type of pain is low back pain.

Learn More about COVID-19 and the COVID-19 Vaccine.