# FDA recall Z-0679-2025

> **Noah Medical** · Class II · device recall initiated 2024-10-25.

## Product

Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

## Reason for recall

Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.

## Distribution

US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC

## Key facts

- **Recall number:** Z-0679-2025
- **Recalling firm:** Noah Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-25
- **Report date:** 2024-12-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0679-2025

## Citation

> AI Analytics. FDA recall Z-0679-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0679-2025. Source: US FDA. Licensed CC0.

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