Guides

Plain-language explanations of the FDA records this site is built on — what they mean and what you can do with them.

• How to Check if Your Medical Device Has Been Recalled
  A step-by-step way to find out whether a recall affects your exact device, and what to do if it does.
• How to Report a Medical Device Problem to the FDA (MedWatch)
  Who can report, what to include and what happens after you report a problem with a medical device to the FDA.
• Class I, II and III Medical Device Recalls: What They Mean
  How the FDA classifies device recalls, what "correction" and "removal" mean, and what a recall status tells you.
• What FDA Adverse Event Reports (MAUDE) Can and Can't Tell You
  Why report counts don't measure how safe a device is, and how to read FDA MAUDE reports usefully.