Recall, early alert, or safety communication?

Recall

FDA uses the term recall when a company or another responsible party takes a correction or removal action to address a problem with a medical device that may violate FDA law. FDA reviews the action and may assign a recall classification.

On MedWatcher, a recall page identifies the regulator, source identifier, status, and source link so the original record remains available.

Early alert

FDA describes an early alert as information about an action that may be the most serious type of recall before FDA has determined whether it meets the regulatory definition of a recall. That distinction matters.

MedWatcher does not label an early alert as a confirmed recall unless the official source has changed its status. We show the source wording and freshness information instead of predicting what will happen next.

Safety communication

A regulator may publish a safety communication or another notice outside the recall database. The notice type, covered products, and recommended actions must be read from that source; a shared manufacturer or product name does not establish that two notices are the same event.

When a public record does not support a match, MedWatcher says so. We do not use an absence of a match as reassurance about a device.

Notice type and record status come from the official source; MedWatcher does not infer either one.