CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Galaxy System recalled by Noah Medical
Noah Medical is recalling Galaxy System, distributed in 20 states. The recall was initiated on 12 Sep 2025 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-0598-2026
- FDA event ID
- 97656
- Recalling firm
- Noah Medical, San Jose, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Sep 2025
- FDA classified
- 25 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Sep 2025 | Recall initiated by company | |
| 25 Nov 2025 | Classified by FDA | +74 days |
| 3 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Product as listed by the FDA
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
Where it was distributed
US distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN, PA, MD, VA, WI, CO, SC, IL, NC and OUS (Foreign) to countries of: Hong Kong and Australia
CaliforniaColoradoIdahoIllinoisIndianaMassachusettsMarylandMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennesseeVirginiaWisconsinWest VirginiaWyoming
Questions about this recall
Why was it recalled?
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Which lots are affected?
Lot Code: Product Code: EOQ UDI: 00850048825048 SN: included in Customer Notification Letter (template) CRB-1502 CRB-1530 CRB-1558 CRB-1503 CRB-1531 CRB-1560 CRB-1508 CRB-1534 CRB-1562 CRB-1513 CRB-1535 CRB-1563 CRB-1514 CRB-1537 CRB-1564 CRB-1515 CRB-1539 CRB-1565 CRB-1516 CRB-1540 CRB-1566 CRB-1518 CRB-1541 CRB-1567 CRB-1519 CRB-1542 CRB-1568 CRB-1520 CRB-1545 CRB-1570 CRB-1521 CRB-1546 CRB-1571 CRB-1522 CRB-1553 CRB-1573 CRB-1523 CRB-1554 CRB-1574 CRB-1524 CRB-1555 CRB-1559 CRB-1525 CRB-1556 CRB-1569 CRB-1528 CRB-1557
Where was it sold?
US distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN, PA, MD, VA, WI, CO, SC, IL, NC and OUS (Foreign) to countries of: Hong Kong and Australia
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 (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 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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