Reported Nov 27, 2024 · Ongoing

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

OrganOx Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: OrganOx Ltd · Magdalen Centre · Oxford, N/A · N/A

Is this the product you have?

  • OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers
  • Model/Catalog NumberD0003 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
Lot codes and dates
  • 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
Amount recalled
20 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new OrganOx Ltd. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.