OrganOx Ltd: Device Recall
Recall #Z-0501-2025 · 10/15/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0501-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- OrganOx Ltd
- Status
- Ongoing
- Date Initiated
- 10/15/2024
- Location
- Oxford, N/A, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Reason for Recall
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Product Description
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.
Distribution Pattern
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.