RegWardenFDA facility compliance records
Facility

Artivion, Inc.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 1 inspections; 2022: 1 inspections; 2024: 2 recalls, 1 inspections2017120182019202020211202220233202420252026
  • Recalls (2)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-05-28
    Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
  • Class IIOngoing2024-03-06
    The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

FDA inspections (3)

  • NAI2024-03-22
    No Action Indicated · Compliance: Devices
  • NAI2022-01-20
    No Action Indicated · Bioresearch Monitoring
  • NAI2018-08-08
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Artivion, Inc. (FEI 3001451326) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001451326-artivion-inc/

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