Class II — XVIVO PERFUSION AB
| Recalling firm | XVIVO Perfusion AB |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. |
| Product | XVIVO Organ Chamber REF 19020 |
| Quantity | 80 devices |
| Distribution | U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland |
| Initiated | 2022-04-08 |
| Classified | 2022-06-01 |
| Terminated | 2025-01-30 |
| Recall number | Z-1212-2022 |
| 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 — XVIVO PERFUSION AB (Z-1212-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90143/
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