Medtech devices and prescription drugs are sometimes the subject of U.S. Food and Drug Administration (FDA) recalls.

The FDA categorizes each recall based on the severity of any identifiable risks.

• A Class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
• A Class II recall is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
• A Class III recall is “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

When the FDA believes an issue is especially serious, it may issue an early alert while the situation is still under investigation. This allows the agency to alert the general public about any ongoing concerns before a final recall classification has occurred.

These recalls are often linked to similar regulatory alerts in other parts of the world as well.