Class II Recall is defined as the drug has a reasonable probability that use or exposure can cause temporary or reversible adverse health consequences or where the probability of harm is remote.

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Class II Recall describes a scenario where there is a reasonable probability that use or exposure to the product can cause temporary or reversible adverse health consequences, or where the probability of harm is remote. This sits between Class I (where there is a reasonable probability of serious adverse health consequences or death) and Class III (where the use or exposure is not likely to cause adverse health consequences). The option that states this exact definition matches the standard for Class II recalls, making it the correct choice. The other statements describe outcomes that fit other recall classes or non-health issues: one implies no risk (Class III), another implies death in all cases (Class I), and a cosmetic issue isn’t a health-related recall classification.