# FDA recall Z-0598-2026

> **Noah Medical Corporation** · Class II · device recall initiated 2025-09-12.

## 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.

## 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

## Key facts

- **Recall number:** Z-0598-2026
- **Recalling firm:** Noah Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-12
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0598-2026

## Citation

> AI Analytics. FDA recall Z-0598-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0598-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*