Class II — Noah Medical
| 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 | 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. |
| Product | Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001) |
| Quantity | 26 |
| Distribution | US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC |
| Initiated | 2024-10-25 |
| Classified | 2024-12-12 |
| Recall number | Z-0679-2025 |
| 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 (Z-0679-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95574/
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