Class II U.S. Food and Drug Administration

Noah Medical Corporation Brand Name: Galaxy System Product Name: Galaxy System Model/ recall: Due to Users not having access to the Instructions for Use/User Manual

Recall published 11 months ago

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0598-2026
Published
December 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Noah Medical Corporation
Product type
Medical devices
Units affected
47
Distribution
California, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, Wisconsin, West Virginia, Wyoming
Made in
United States
Lot / code info
Lot Code: Product Code: EOQ UDI: 00850048825048 SN: included in Customer Notification Letter (template) CRB-1502 CRB-1530 CRB-1558 CRB-1503 CRB-1531 CRB-1560 CRB-1508 CRB-1534 CRB-1562 CRB-1513 CRB-1535 CRB-1563 CRB-1514 CRB-1537 CRB-1564 CRB-1515 CRB-1539 CRB-1565 CRB-1516 CRB-1540 CRB-1566 CRB-1518 CRB-1541 CRB-1567 CRB-1519 CRB-1542 CRB-1568 CRB-1520 CRB-1545 CRB-1570 CRB-1521 CRB-1546 CRB-1571 CRB-1522 CRB-1553 CRB-1573 CRB-1523 CRB-1554 CRB-1574 CRB-1524 CRB-1555 CRB-1559 CRB-1525 CRB-1556 CRB-1569 CRB-1528 CRB-1557
UPC codes
00850048825048

Products covered by this recall

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00850048825048

Model or item number

On the rating label, the box or the instruction sheet.

  • EOQ UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Noah Medical Corporation — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Noah Medical Corporation — 2075 Zanker Rd, San Jose, CA, 95131-2107

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Noah Medical Corporation medical devices recalled?

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00850048825048; model number EOQ UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists California, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York and others.

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