Class II — Noah Medical Corporation
| Recalling firm | Noah Medical |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| 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. |
| Quantity | 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 |
| Initiated | 2025-09-12 |
| Classified | 2025-11-25 |
| Recall number | Z-0598-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Noah Medical Corporation (Z-0598-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97656/
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