Class II — OrganOx Ltd
| Recalling firm | OrganOx Limited |
|---|---|
| Registered facility | ORGANOX LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket |
| Product | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. |
| Quantity | 20 units |
| Distribution | California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia. |
| Initiated | 2024-10-15 |
| Classified | 2024-11-21 |
| Recall number | Z-0501-2025 |
| 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 — OrganOx Ltd (Z-0501-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95581/
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