Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog… — Class II medical device recall Z-0598-2026
Ongoing recall by Noah Medical Corporation, reported 2025-12-03, distributed in CA, CO, ID, IL, IN, MA, MD, MN…. Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
| Recall number | Z-0598-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noah Medical Corporation, San Jose, CA, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-11-25 |
| Reported by FDA | 2025-12-03 |
| Distributed | CA, CO, ID, IL, IN, MA, MD, MN, MO, NC, NJ, NY, OH, PA, SC, TN, VA, WI, WV, WY |
| Countries outside the US | AU, HK |
| Quantity | 47 |
| UPC / GTIN / UDI-DI | 00850048825048 |
| Model numbers | GAL-001 |
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.
Reason for recall
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0598-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.