The Recall Desk
HighFDA (Devices)·Z-0501-2025·Announced 2024-11-27

OrganOx metra Liver Perfusion System Recalled for Battery Damage

OrganOx Ltd is recalling 20 metra liver perfusion systems because battery movement caused a cell to short against the retention bracket.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a battery short circuit hazard where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

OrganOx Ltd is recalling 20 units of the OrganOx metra Normothermic Machine Perfusion system, Model D0003. The device is a transportable system intended to sustain donor livers destined for transplantation in a functioning state for up to 12 hours.

The recall was initiated because battery movement led to damage of one of the battery cells, causing it to short to the battery retention bracket. The affected units are identified by UDI-DI 05060462240029 and specific serial numbers ranging from 511 to 537.

The affected units were distributed in California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina, and Georgia. Users should stop using the device and contact the manufacturer for instructions.

The recalled product

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
Manufacturer
OrganOx Ltd
Category
Medical Device — Organ Perfusion System
Hazard
Affected units
20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 10 states:

Related recalls

Same hazard · battery short circuit

See all →