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    FDA Recall Classifications I, II, III

    FDA's risk-based grading of recalls based on potential for harm.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Class I recalls involve a reasonable probability of serious adverse health consequences or death; Class II involves temporary or medically reversible harm; Class III is unlikely to cause adverse health consequences.

    What this means in practice

    Classification determines public notification expectations and effectiveness-check rigor. The Recall Strategy and Health Hazard Evaluation drive the classification decision.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      FDA Recall Procedures
      Verified
      FDAfda.gov
    2. 2
      FDA Recalls - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      EUDAMED Public Site
      Verified
      European Commissionec.europa.eu

    Inline markers like [1] jump to the matching reference above.