Galaxy System — Class II medical device recall Z-0742-2025
Ongoing recall by Noah Medical, reported 2025-01-01, distributed in CA, CT, ID, IN, MA, MD, MO, NC…. Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpe
| Recall number | Z-0742-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noah Medical, San Carlos, CA, United States |
| Recall initiated | 2024-10-28 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | CA, CT, ID, IN, MA, MD, MO, NC, NJ, NY, OH, PA, SC, TN, WV |
| Quantity | 18 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00850048825048 |
| Serial numbers | CRB-1502, CRB-1503, CRB-1506, CRB-1508, CRB-1516, CRB-1517, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1527, CRB-1528, CRB-1529, CRB-1530, CRB-1532 |
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Reason for recall
Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
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-0742-2025. 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.