Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients, caregivers, and health care providers about certain recalled ResMed Ltd (ResMed) masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines. These recalled masks have magnets that can cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices or metallic objects in the body.
These potential adverse events can occur in people who use the masks or in people near a person using the mask. Additionally, the recalled ResMed masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see if their mask is one of the recalled ResMed masks.
The safety communication provides:
- A list of recalled masks.
- Potential risks if magnets affect the functioning or cause movement of certain implanted metallic medical devices or metallic objects in the body.
- Recommendations for people who use a recalled mask, people near a person using the mask, caregivers, and health care providers.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with a recalled mask to the FDA.
Questions?
If you need any more information or support about this issue, please contact ResMed customer service online or by phone at 1 (800) 424-0737
If you have questions about this safety communication, contact the Division of Industry and Consumer Education.
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.