{
  "schema": "upg.factor.v1",
  "id": "ptce/safety/recall-classes",
  "exam": [
    "PTCE"
  ],
  "domain": "Patient Safety & Quality Assurance",
  "title": "FDA recall classes I / II / III",
  "claim": "FDA classifies recalls by relative health hazard: Class I — reasonable probability that use/exposure will cause serious adverse health consequences or death; Class II — use/exposure may cause temporary or medically reversible adverse health consequences, or probability of serious consequences is remote; Class III — use/exposure is not likely to cause adverse health consequences. Class is assigned by FDA; market withdrawal is a different action for minor issues not rising to FDA legal action.",
  "plain": "I = serious harm/death likely. II = temporary/reversible or serious harm remote. III = unlikely to cause harm. Know the three classes; don’t confuse with market withdrawal.",
  "confidence": 0.97,
  "citations": [
    {
      "authority": "FDA — Recalls Background and Definitions",
      "url": "https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions",
      "pin": "FDA recall Class I / II / III definitions",
      "retrieved_at": "2026-09-08",
      "quote": "Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: 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. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences."
    }
  ],
  "updated_at": "2026-09-08",
  "token_cost_hint": 220,
  "integrity": "practice_only",
  "html": "/factors/ptce/safety/recall-classes",
  "json": "/factors/ptce/safety/recall-classes.json"
}