CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report

metra -Intended as a Normothermic Machine Perfusion system recalled

OrganOx is recalling metra -Intended as a Normothermic Machine Perfusion system of donor transport livers, distributed in 11 states. The recall was initiated on 15 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0501-2025
FDA event ID: 95581
Recalling firm: OrganOx, Oxford, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 15 Oct 2024
FDA classified: 21 Nov 2024
Reported: 27 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

15 Oct 2024	Recall initiated by company
21 Nov 2024	Classified by FDA	+37 days
27 Nov 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.

California District of Columbia Florida Georgia Massachusetts New York Ohio Oklahoma South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Which lots are affected?

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

Where was it sold?

California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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