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    Medical Device Recall

    Removal or correction of a marketed device that violates FDA law.

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

    Definition

    Per 21 CFR Part 7, a recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action. Classes I–III reflect risk of serious health consequences.

    What this means in practice

    Most recalls are voluntary. A FDA-mandated recall is rare but possible. Recall data is publicly available.

    Cross-references

    Contains

    Sub-elements or required artefacts of this term.

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1European Commission·1MDCG·1
    1. 1
      FDA Recall Information
      Verified
      FDAfda.gov
    2. 2
      EUDAMED Public Site
      Verified
      European Commissionec.europa.eu
    3. 3
      MDCG Vigilance Guidance
      Verified
      MDCGhealth.ec.europa.eu

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