What is a Class II recall?

A Class II recall is defined as a situation where the use of or exposure to a product may cause temporary or medically reversible adverse health consequences. This type of recall is initiated when there is concern that a product could potentially harm consumers, but the risks are not as severe as in a Class I recall, where the use of the product is likely to result in serious health consequences or death.

By stating that the consequences are temporary or medically reversible, this classification indicates that while there is a risk involved, the expected outcomes are not life-threatening, and health care intervention or treatment can mitigate the effects. This distinguishes it from the Class I recall, which involves much more serious health risks, and from Class III recalls, where the products are unlikely to cause any adverse health effects.

The emphasis in a Class II recall is on the potential for harm that is manageable rather than imminent, representing a proactive approach to safeguarding public health while still recognizing the presence of risk.