A Class I recall is issued when products could cause what?

• A. Could cause temporary minor injury
• B. Could cause serious injury or death
• C. No risk to health
• D. Product description issue

Answer: (B)

Class I recalls signal the most serious safety risk. They’re issued when there is a reasonable probability that the use of or exposure to a product could cause serious adverse health consequences, including death. This category is used for situations where harm could be life-threatening, such as a medical device that could deliver a fatal dose or a contamination that could cause death. By contrast, recalls tied to temporary or reversible injuries fall into a less severe category, while issues like no health risk or purely labeling/documentation problems don’t meet the threshold for a recall. So the recall is issued when products could cause serious injury or death.