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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 September 19, 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. FDA assigns the class after a health hazard evaluation, considering things like the likelihood of harm, the severity and the population at risk. Class I recalls get the most attention: FDA typically issues public notices and expects the firm to check effectiveness at the user level. Classification affects how widely the firm must notify customers and how FDA checks that the recall is complete.
    What the regulation says
    The FDA categorizes medical device recalls into three classes, I, II, and III, based on the degree of health hazard. This classification, outlined in 21 CFR Part 7, Subpart C, dictates the urgency and scope of action required from the recalling firm and the FDA. The FDA’s Regulatory Procedures Manual (RPM) Chapter 7 provides further guidance on recall policies and procedures.

    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.

    Examples

    • A manufacturer discovers a software bug in an implanted cardiac device that could cause it to stop functioning, leading to patient death. This would likely result in a Class I recall.
    • A sterile surgical instrument is found to have minor, non-critical packaging defects that do not compromise sterility but might lead to user confusion. This could lead to a Class III recall.
    • A diagnostic test kit produces slightly inaccurate results that could lead to a temporary misdiagnosis, but without permanent patient harm. This condition often results in a Class II recall.
    Common pitfalls
    • •Misinterpreting a Class II recall as less critical, potentially delaying appropriate corrective actions.
    • •Failing to conduct a thorough Health Hazard Evaluation, which can lead to an incorrect recall classification.
    • •Underestimating the resources required for a Class I recall, impacting the speed and effectiveness of product removal.
    • •Not understanding that even Class III recalls require proper documentation and communication with the FDA.
    • •Assuming that a recall classification is permanent and cannot be re-evaluated if new information arises.

    Frequently asked questions

    The primary factor is the Health Hazard Evaluation (HHE), which assesses the probability of adverse health consequences and their severity.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
    Link health: 2 verified 1 unchecked· last checked 2026-06-20
    eCFR·1FDA·1European Commission·1
    1. 1
      21 CFR Part 7, Recalls
      Tier 1 Unchecked
      eCFRecfr.gov
    2. 2
      FDA Recalls - Medical Devices
      Tier 2 Verified
      FDAfda.gov
    3. 3
      EUDAMED Public Site
      Tier 2 Verified
      European Commissionec.europa.eu

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