FDA Device recall Z-0501-2025
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers by Organox, citing battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0501-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Organox |
| Distribution | CA, DC, FL, GA, MA, NY, OH, OK, SC, TX, VA |
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.
Reason
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Identifiers
| code_info | UDI-DI: 05060462240029 Serial numbers 511, 512, 514, 515, 516, 517, 518, 519, 520, 522, 523, 524, 525, 527, 528, 529, 530, 531, 533, 535, 536, 537 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2025%22
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