Noah Medical Corporation recalls Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy Sys…

Recall date

September 12, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0598-2026

FDA classification

Class II

Brand / firm

Noah Medical Corporation

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.