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  1. Resources for You (Medical Devices)

Consumers (Medical Devices)


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Popular Topics

illustration of a man seated using a oxygen concentrator and hand with index finger inserted into a pulse oximeter

Pulse Oximeters and Oxygen Concentrators
Hands holding CPAP mask assembly. Cleaning CPAP Machines and Accessories.

Cleaning CPAP Devices and Accessories

Closeup of doctor and patient hands holding and touching breast implants.

Breast Implants
Image of a Microneedling Device.
Image of a Microneedling Device.

Microneedling Devices

Medical Device Safety

Medical Device Safety Communications

The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients.

Medical Device Recalls

FDA uses the term "recall" when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Medical Device Safety

Consumer Updates

From simple items like tongue depressors and bedpans to complex technologies such as pacemakers, surgical implants and prosthetics, learn how FDA-regulated medical devices affect you.

Medical Device Safety

Female doctor meeting with female patient and pointing to a gynecological diagram. Making Laparoscopic Power Morcellators Safer.​

Making Laparascopic Power Morcellators Safer
Photo of a woman holding silicone breast implants in her hand

Allergan Recalls BIOCELL® Textured Breast Implants and Tissue Expanders

How do I report a problem with a Medical Device?

MedWatch

You are encouraged to file a voluntary report by phone at 1-800-332-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program if you have experienced a problem with a medical device.

FDA Consumer Complaint Coordinator

You may also wish to report adverse reactions or other problems with FDA regulated products. To do so, contact the FDA Consumer Complaint Coordinator for the state in which you reside.

Consumer Topics A-C

Consumer Topics D-Z

Resources for You

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Contact Us

Contact Point
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

DICE@fda.hhs.gov

(800) 638-2041
(301) 796-7100

Hours Available

Office of Communication and Education

For Updates on Twitter follow

Contact Point Twitter

@FDADeviceInfo

Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.


Subscribe to Consumer Information for Medical Devices

Receive notifications for consumers about medical device information, recently approved devices, and alerts that may be of interest to the general public.

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