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    Counterfeit Parts and Suspect Components

    Risk of unauthorized, fraudulent, or substandard components entering the supply chain.

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

    Definition

    Counterfeit electronic components and substandard materials have caused field failures and recalls in MedTech. Mitigation includes authorized-distributor sourcing, incoming inspection, and AS6081/AS6171-style detection methods for electronics.

    What this means in practice

    Heightened concern after EUA-era ventilator and respirator supply chains exposed widespread component fraud.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    SAE·1FDA·1ISO·1
    1. 1
      SAE AS6081
      Verified
      SAEsae.org
    2. 2
      FDA - Device Manufacturing
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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