OrganOx metra -Intended as a Normothermic Machine Perfusion… recallZ-0501-2025 · OrganOx Ltd · initiated Oct 15, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OrganOx Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-0501-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 15, 2024
- Posted by the FDA
- Nov 21, 2024
- Recalling firm
- OrganOx Ltd
- Quantity
- 20 units
- Product code
- QQK
- FDA submissions
- P200035
- Distribution
- California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
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.
Code information (models, lots, serial 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OrganOx metra D0146Organox Limited · Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation1 recall14 reports
Other devices under the same FDA submission
1 device cleared under P200035 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OrganOx metra D0003Organox Limited · Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation1 death72 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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