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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

OrganOx metra Perfusion System Recalled for Battery Short Circuit Risk

Agency Publication Date: November 21, 2024
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Summary

OrganOx Ltd is recalling 20 units of the OrganOx metra (Model D0003), a transportable device used to sustain donor livers for transplantation for up to 12 hours. The recall was initiated because movement of the internal battery can damage a battery cell, potentially causing it to short-circuit against the retention bracket. No injuries have been reported to date.

Risk

A battery short circuit can cause the device to lose power or malfunction while it is being used to preserve a donor liver. This could lead to damage to the organ or failure of the transplant procedure.

What You Should Do

  1. This recall affects the OrganOx metra Perfusion System, a device used to transport and sustain donor livers for transplantation.
  2. Check the device label for Model/Catalog Number D0003 and the serial number. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact OrganOx Ltd or your medical distributor to arrange for a return, replacement, or correction of the battery system.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: OrganOx metra Perfusion System
Model / REF:
D0003
Serial Numbers:
511
512
514
515
516
517
518
519
520
522
523
524
525
527
528
529
530
531
533
535
536
537
UDI:
05060462240029

Intended as a Normothermic Machine Perfusion system for donor transport livers.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95581
Status: Active
Manufacturer: OrganOx Ltd
Sold By: Specialty medical distributors; OrganOx Ltd
Manufactured In: United Kingdom
Units Affected: 20 units
Distributed To: California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, District of Columbia, South Carolina, Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.