XVIVO Organ Chamber REF 19020 — Class II medical device recall Z-1212-2022
Terminated recall by XVIVO PERFUSION AB, reported 2022-06-08, distributed in CA, FL, MA, NC, NY, OH, PA, TX. The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guarante
| Recall number | Z-1212-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | XVIVO PERFUSION AB, Goteborg, N/A, Sweden |
| Recall initiated | 2022-04-08 |
| Classified | 2022-06-01 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2025-01-30 |
| Distributed | CA, FL, MA, NC, NY, OH, PA, TX |
| Countries outside the US | AT, CA, FR, IE, IT |
| Quantity | 80 devices |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 07350069520074 |
| Lot numbers | 13801, 13802, 13803, 13804, 13805, 13806 |
| Model numbers | 19020 |
Product
XVIVO Organ Chamber REF 19020
Reason for recall
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1212-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.