Z-0679-2025Class II

Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah...

Name: Z-0679-2025 Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah...
Creator: Noah Medical
Published: 2024-10-25
License: https://open.fda.gov/license/

NOAH MEDICAL Corp. / initiated 2024-10-25 / Open, Classified / root cause: design

FDA source

Noah Medical began a recall of Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001) on 2024-10-25. FDA classified it as Class II and gives the reason as "Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0679-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-25
Posted: 2024-12-13
Recalling firm: NOAH MEDICAL Corp.
Product: Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/25/24, recall notices were sent to customers who were asked to do the following: A copy of this letter should be kept with the instructions for use which adds additional warnings and precautions to the section Working Channel Tools/Instruments on page 23 of the Instructions for Use. CAUTION: If the bending section of the bronchoscope is articulated sharply and advancement of a biopsy tool encounters increased insertion resistance, straighten the bending section as much as possible to enable resumed advancement of the tool. Use of excessive force during instrument insertion may damage the instrument and/or the bronchoscope or result in tissue injury including pneumothorax. Certain instruments with longer rigid distal sections may exhibit increased insertion resistance when bronchoscope bending section is significantly articulated. Firm has undertaken an investigation of which types of biopsy tools are most likely to result in binding and will make this information available as testing is completed. A replacement to the Instructions for Use with the Cautions herein and replacement instructions will be made available. Firm is also investigating technical solutions to make the working channel of the bronchoscope compatible with a wider range of biopsy tools and a wide degree of conformations in use. Share this notification with any other healthcare professionals who may use the system. Complete and return the response form. Firm customer Service: [email protected], 888-325-6624
Quantity in commerce: 26
Distribution: US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
Product codes and lots: UDI-DI: 00850048825048. IFU Revision: J and all prior versions. All bronchoscope lots used with the following system serial numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB1540, CRB-1541, CRB-1543, CRB1554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0679-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0679-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-12

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)