Device recall
Z-0501-2025: OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor…
FDA device recall · Class II · OrganOx Ltd
Key facts
| Recall number (Z-number) | Z-0501-2025 |
|---|---|
| Recall event | 95581 |
| 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… |
| Product code | QQK |
| Recalling firm | OrganOx Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P200035 |
| FEI number | 3011560054 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database