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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Noah Medical Galaxy System Recalled for Power Supply Failure Risk

Agency Publication Date: December 20, 2024
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Summary

Noah Medical is recalling 18 units of its Galaxy System (GAL-001), which is used by doctors to view and access a patient's airways during medical procedures. The power supplies in these systems contain defective components that can fail without warning. If the system fails while in use, the procedure must be stopped, and the medical team may have to manually remove the bronchoscope from the patient. While no injuries have been reported to date, this failure requires the manufacturer to correct or replace the affected equipment.

Risk

If the power supply fails during a procedure, the system will stop functioning. Manually removing the bronchoscope when the system is off increases the risk of damaging lung tissue and could lead to a collapsed lung (pneumothorax).

What You Should Do

  1. This recall affects Noah Medical Galaxy System (GAL-001) visualization systems with UDI-DI 00850048825048. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately.
  3. Contact Noah Medical or your authorized distributor to arrange for a return, replacement, or correction of the equipment.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have 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: Galaxy System (GAL-001)
Model / REF:
GAL-001
Serial Numbers:
CRB-1502
CRB-1503
CRB-1506
CRB-1508
CRB-1516
CRB-1517
CRB-1519
CRB-1520
CRB-1521
CRB-1522
CRB-1523
CRB-1524
CRB-1525
CRB-1527
CRB-1528
CRB-1529
CRB-1530
CRB-1532
UDI:
00850048825048

Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95585
Status: Active
Manufacturer: Noah Medical
Sold By: Noah Medical Authorized Distributors
Manufactured In: United States
Units Affected: 18
Distributed To: South Carolina, Ohio, Pennsylvania, Tennessee, Missouri, Indiana, California, West Virginia, New York, Maryland, Massachusetts, New Jersey, Idaho, Connecticut, North Carolina

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.