# FDA recall Z-0501-2025

> **OrganOx Ltd** · Class II · device recall initiated 2024-10-15.

## 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

## Distribution

California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.

## Key facts

- **Recall number:** Z-0501-2025
- **Recalling firm:** OrganOx Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-15
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oxford, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2025

## Citation

> AI Analytics. FDA recall Z-0501-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0501-2025. Source: US FDA. Licensed CC0.

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