FDA Medical Device Recalls (openFDA)
OrganOx Ltd: 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.
- Recall number
- Z-0501-2025
- Recalling firm
- OrganOx Ltd
- 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.
- Status
- Open, Classified
- Initiated
- 2024-10-15
- Posted
- 2024-11-21
- Terminated
- not on file
- Reason
- Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
- 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 Michael.donahue@organox.com +1 732-948-2175
- Quantity
- 20 units
- Distribution
- California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P200035"]
- Product code
- QQK
- Firm FEI
- 3011560054
- Firm city
- Oxford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28