FDA Medical devices recall ·
OrganOx metra -Intended as a Normothermic Machine Perfusion system of… recall
- Recall number
- Z-0501-2025
- Date
- (initiated October 15, 2024)
- Company / brand
- OrganOx Ltd
Magdalen Centre, Oxford, N/A, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
States: California District of Columbia Florida Georgia Massachusetts New York Ohio Oklahoma South Carolina Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0501-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.