Class II — Artivion, Inc
| Recalling firm | Artivion, Inc. |
|---|---|
| Registered facility | Artivion, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| Product | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology. |
| Quantity | 2 valves |
| Distribution | US Nationwide distribution in the states of CA, DC, FL, and NY. |
| Initiated | 2024-05-28 |
| Classified | 2024-08-08 |
| Recall number | Z-2531-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Artivion, Inc (Z-2531-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94909/
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