Recall Classification (US)

The Class I, II, or III designation the FDA assigns to a product recall to show the relative health hazard of the recalled product. The FDA makes the assignment, not the recalling firm. Class I is the most serious and Class III the least.

Using or being exposed to the product

Class I

Has a reasonable probability of causing serious adverse health consequences or death.

Class II

May cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.

Class III

Is not likely to cause adverse health consequences.

Where it is written

21 CFR 7.3(m)

Also called

FDA recall classification, Class I recall, Class II recall, Class III recall

Related terms