Z-0501-2025Class II

OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog...

Name: Z-0501-2025 OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog...
Creator: OrganOx Ltd
Published: 2024-10-15
License: https://open.fda.gov/license/

OrganOx Limited / initiated 2024-10-15 / Open, Classified / root cause: design

FDA source

OrganOx Ltd began a recall of OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable... on 2024-10-15. FDA classified it as Class II and gives the reason as "Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0501-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-15
Posted: 2024-11-21
Recalling firm: OrganOx Limited
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.
Product code: QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Reason for recall: Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Root cause tag: design
FDA root cause: Device Design
Action: OrganOx issued Important Field Correction Notice letter on 10/15/24 via Fed'X. letter states reason for recall, health risk and action to take: As a result of the investigation into this event, OrganOx has implemented a secondary battery retention mechanism to prevent battery movement due to jarring or impact that could be related to machine transport or movement. The secondary battery retention mechanism will be installed on your machine by OrganOx service personnel no later than 15 December 2024. Recommendations: The metra in your possession continues to be safe and effective in anticipation of this correction and the machine may be used as normal. Should an unexpected rapid decrease in battery voltage occur as noted by alarm from the metra, please determine the impact to the perfusion event and take action if needed. Should this occur, please follow the OrganOx complaints reporting process and quarantine the machine until it can be serviced. Should you have questions about this important Field Correction please contact: Michael Donahue [email protected] +1 732-948-2175
Quantity in commerce: 20 units
Distribution: California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0501-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0501-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-21

Product code QQK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)