Glossary › Class I Recall

GLOSSARYUS

Class I Recall

The most serious recall class. The FDA assigns it where there is a reasonable probability that using or being exposed to the violative product will cause serious adverse health consequences or death.

Where it is written: 21 CFR 7.3(m)(1)
Also called: Class 1 recall

Avoid This Mistake

The wording matches the first part of the Part 806 definition of risk to health.

Related terms

Recall Recall Classification Class II Recall Risk to Health

All Terms