OrganOx metra -Intended as a Normothermic Machine Perfusion system of… — Class II medical device recall Z-0501-2025
Ongoing recall by OrganOx Ltd, reported 2024-11-27, distributed in CA, DC, FL, GA, MA, NY, OH, OK…. Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracke
| Recall number | Z-0501-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrganOx Ltd, Oxford, N/A, United Kingdom |
| Recall initiated | 2024-10-15 |
| Classified | 2024-11-21 |
| Reported by FDA | 2024-11-27 |
| Distributed | CA, DC, FL, GA, MA, NY, OH, OK, SC, TX, VA |
| Quantity | 20 units |
| UPC / GTIN / 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 |
| Model numbers | D0003 |
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 for recall
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
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-0501-2025. 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.