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 | Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. |
| Product | Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. |
| Quantity | 17 wired controllers |
| Distribution | U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA. |
| Initiated | 2024-03-09 |
| Classified | 2024-05-01 |
| Recall number | Z-1734-2024 |
| 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-1734-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94193/
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