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Recall Classification (I, II, III)

The FDA's three-level system that ranks how dangerous a recalled product is, from life-threatening (I) to a labeling-only issue (III).

Every FDA recall gets a class that signals how much danger the product poses. The class is assigned by the FDA after a health hazard evaluation, not by the company. Class I means a reasonable probability of serious harm or death. Class II means the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. Class III means using the product is not likely to cause harm, but it breaks an FDA law, usually a labeling or manufacturing rule. The class matters because it tells you what to do. A Class I recall means stop and dispose immediately. A Class II might mean the product is fine for most people but risky for a specific group, like an undeclared trace allergen. A Class III is often a paperwork or labeling fix with no real health risk to most consumers. Most consumer-facing recalls in the news are Class I or Class II. Class III recalls happen constantly but rarely make headlines because they carry little health risk. When you filter by class in a recall tool, starting with Class I is the fastest way to see what actually deserves your attention.

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