CLASS II ONGOING Device recall · Reported 18 Dec 2024 · FDA Enforcement Report
Galaxy bronchoscope (Product Galb-001) used recalled by Noah Medical
Noah Medical is recalling Galaxy bronchoscope (Product Galb-001) used with Instructions for use, Part: 10000752, distributed nationwide in the US. The recall was initiated on 25 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-0679-2025
- FDA event ID
- 95574
- Recalling firm
- Noah Medical, San Carlos, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Oct 2024
- FDA classified
- 12 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Oct 2024 | Recall initiated by company | |
| 12 Dec 2024 | Classified by FDA | +48 days |
| 18 Dec 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Where it was distributed
US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
Nationwide CaliforniaConnecticutIdahoIndianaMassachusettsMarylandMissouriNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennesseeWest Virginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00850048825048. IFU Revision: J and all prior versions. All bronchoscope lots used with the following system serial numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB1540, CRB-1541, CRB-1543, CRB1554
Where was it sold?
US Nationwide Distribution: 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 | 15 states |
| Device | CLASS II | Galaxy System (GAL-001) recalled by Noah Medical | Noah Medical | Device Malfunction | 16 states |
| Device | CLASS II | Galaxy System recalled by Noah Medical | Noah Medical | Other | Nationwide |
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