Oxford, N/A, United Kingdom
OrganOx Ltd recalls
1 recall recorded since 2018, most recently on 15 October 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 October 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0501-2025
- 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 dest
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.