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Multiple Choice

Which class of recall indicates use or exposure is not likely to cause adverse health consequences?

Classifications of recalls reflect how likely a use or exposure is to harm patients. When the risk is minimal and unlikely to cause adverse health effects, the appropriate category is a Class III recall. These issues are typically minor and do not affect safety or efficacy—think of labeling or packaging problems, or deviations that don’t impact how the product works. By contrast, Class I involves a reasonable probability of serious adverse health consequences or death, and Class II involves temporary or reversible adverse health effects or a remote chance of harm. So, the situation described—use or exposure not likely to cause adverse health consequences—fits Class III.

Classifications of recalls reflect how likely a use or exposure is to harm patients. When the risk is minimal and unlikely to cause adverse health effects, the appropriate category is a Class III recall. These issues are typically minor and do not affect safety or efficacy—think of labeling or packaging problems, or deviations that don’t impact how the product works. By contrast, Class I involves a reasonable probability of serious adverse health consequences or death, and Class II involves temporary or reversible adverse health effects or a remote chance of harm. So, the situation described—use or exposure not likely to cause adverse health consequences—fits Class III.