Z-0598-2026Class II

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The...

Name: Z-0598-2026 Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The...
Creator: Noah Medical Corporation
Published: 2025-09-12
License: https://open.fda.gov/license/

NOAH MEDICAL Corp. / initiated 2025-09-12 / Open, Classified / root cause: labeling and UDI

FDA source

Noah Medical Corporation began a recall of Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended... on 2025-09-12. FDA classified it as Class II and gives the reason as "Due to Users not having access to the Instructions for Use/User Manual due to it being password protected". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0598-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-12
Posted: 2025-11-26
Recalling firm: NOAH MEDICAL Corp.
Product: 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.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 09/12/2025, the firm sent via FedEx an "Urgent: MEDICAL DEVICE RECALL" Letter to customers. The letter described the product, risk to health and action to be taken. Customers were notified that the password has been removed and they are instructed to: Log in and access the applicable IFU and all addendums. Noah Medical recommends that customers download the IFU and addendums for ease of reference. For questions contact: Noah Medical Customer Service email: [email protected] Noah hotline: 888-325-NOAH (1-888-325-6624)
Quantity in commerce: 47
Distribution: US distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN, PA, MD, VA, WI, CO, SC, IL, NC and OUS (Foreign) to countries of: Hong Kong and Australia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0598-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0598-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-25

Product code EOQ

K223144Class IIGalaxy SystemNoah Medical Corp. / cleared 2023-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)