Which classification of recall is associated with serious health consequences or death?

Class I recalls are designated for situations where there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death. This classification indicates the highest level of risk associated with a product's defect or contamination.

In the context of pharmaceuticals or medical devices, a Class I recall often involves products that are either misbranded or adulterated in a way that poses a significant threat to patient safety. The urgency and severity of such recalls require immediate action, including the removal of the product from the market and notification to healthcare professionals and consumers.

Class II recalls pertain to products that may cause a temporary or medically reversible adverse health effect or where the probability of serious adverse consequences is remote. On the other hand, Class III recalls involve products that are not likely to cause any adverse health consequences. Therefore, Class I recalls are specifically tied to serious outcomes, making this classification crucial for ensuring public health safety.