If a drug or medical device causes temporary adverse health consequences, it is classified as which type of recall?

A drug or medical device that causes temporary adverse health consequences falls under Class II recall. This classification indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health effects, or there is a possibility of serious effects later on.

Class II recalls are generally initiated to protect patients and consumers, prompting action to remove the product from circulation. The focus in a Class II recall is on the potential health impact that might require medical attention, but it is not expected to be life-threatening.

In contrast, a Class I recall involves situations where there is a reasonable probability that the product will cause serious adverse health consequences or death. Class III recalls are for products that are not likely to cause any adverse health effects, and voluntary recalls are actions taken by manufacturers to withdraw products without being mandated by regulating bodies, which can fall into any of the three classification categories based on the associated risk.