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    Removal vs Correction (21 CFR 806)

    Reporting categories for field actions: removal physically retrieves the device; correction modifies it in place.

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

    Definition

    Manufacturers must report to FDA within 10 working days corrections or removals initiated to reduce health risk or remedy violations. Some actions are exempt (e.g., normal service, market withdrawal not for safety/violation).

    What this means in practice

    806 reporting is separate from recall classification; the two systems intersect but have distinct triggers and timelines.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1FDA·1European Commission·1
    1. 1
      21 CFR 806
      Verified
      eCFRecfr.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.