Noah Medical Corporation: Device Recall
Recall #Z-0598-2026 · 09/12/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0598-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Noah Medical Corporation
- Status
- Ongoing
- Date Initiated
- 09/12/2025
- Location
- San Jose, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47
Reason for Recall
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Product Description
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.
Distribution Pattern
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.