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Glossary · Tier 1

Class II Recall

Also known as: Class 2 Recall, FDA Class II Recall

Verified from eCFR 21 CFR 7.3 on 06-02-2026
Quick answer

Class II Recall is one of three tiers the FDA uses to rank the health risk of a recalled product. It sits between Class I (the highest-risk tier) and Class III (the lowest-risk tier), and signals that potential health consequences are generally temporary, reversible, or unlikely to be serious. The authoritative definition from the U.S. Office of the Federal Register follows below.

MedivaScan summary. The authoritative source quote follows below.

eCFR 21 CFR 7.3 definition

Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

U.S. Office of the Federal RegisterView on source ›Verbatim quote. Last verified 06-02-2026.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.