Class II

Medical Device 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

Noah Medical Corporation · September 12, 2025

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

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

States Affected

CA, CO, ID, IL, IN, MA, MD, MN, MO, NC, NJ, NY, OH, PA, SC, TN, VA, WI, WV, WY

Quantity Affected

47

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0598-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Noah Medical Corporation Medical Device 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 | SafeCheck