RegWardenFDA facility compliance records
Company

Artivion, Inc.

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

Recalls by year

FDA actions on record by year2024: 2 recalls20172018201920202021202220232202420252026
  • Recalls (2)

Registered facilities (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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Artivion, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9003683-artivion-inc/

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