CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Galaxy System (GAL-001) recalled by Noah Medical
Noah Medical is recalling Galaxy System (GAL-001), distributed in 15 states. The recall was initiated on 28 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0742-2025
- FDA event ID
- 95585
- Recalling firm
- Noah Medical, San Carlos, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Oct 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Oct 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +53 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Where it was distributed
US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
CaliforniaConnecticutIdahoIndianaMassachusettsMarylandMissouriNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennesseeWest Virginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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,
Where was it sold?
US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Noah Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Galaxy System recalled by Noah Medical | Noah Medical | Other | 20 states |
| Device | CLASS II | Galaxy System (GAL-001) recalled by Noah Medical | Noah Medical | Device Malfunction | 16 states |
| Device | CLASS II | Galaxy bronchoscope (Product Galb-001) used recalled by Noah Medical | Noah Medical | Other | Nationwide |
| Device | CLASS II | Galaxy System recalled by Noah Medical | Noah Medical | Other | Nationwide |
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