Recall archive / FDA device enforcement
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D... — FDA record Z-0501-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
- Classification
- Class II
- Recalling firm
- OrganOx Ltd
- Quantity
- 20 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0501-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 15, 2024
- Center classification date
- Nov 21, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.