OrganOx Ltd recalls OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D00…

Recall date

October 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0501-2025

FDA classification

Class II

Brand / firm

OrganOx Ltd

Sold / distributed

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

Why it was recalled

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.