Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- Noah Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Noah Medical
- Product type
- Bronchoscopy Visualization System
- Model numbers
- GAL-001, CRB-1502, CRB-1530, CRB-1558, CRB-1503, CRB-1531, CRB-1560, CRB-1508 +43 more
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Noah Medical Corporation or your healthcare provider for instructions. Notification method: N/A
About This Product
The Galaxy System is a bronchoscopic visualization device used to visualize and access airways for diagnostic and therapeutic procedures.
Why This Is Dangerous
Access to essential operating instructions is compromised by password protection, creating the potential for improper use during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and providers may experience procedure delays or need to stop using affected devices until recall instructions are followed.
Practical Guidance
How to identify if yours is affected
- Verify device model GAL-001
- Refer to Customer Notification Letter for listed lot codes (e.g., CRB-1502, CRB-1530, CRB-1558, etc.)
- Check UDI 00850048825048 on the device or packaging
- Confirm distribution region (US states listed or international)
Where to find product info
Recall notice and instructions are on the FDA enforcement page and Noah Medical communications.
What timeline to expect
Not specified in the provided data.
If the manufacturer is unresponsive
- Escalate to hospital risk management and the FDA recall process if the manufacturer is unresponsive.
- Document attempts to contact and actions taken.
How to prevent similar issues
- When introducing devices, ensure manuals and IFUs are accessible to staff.
- Request electronic IFUs from vendors to prevent password lockouts.
- Verify device readiness with up-to-date recall information before procedures.
Documentation advice
Retain the recall letter, document device identifiers, and log communications with the manufacturer for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model: GAL-001. Brand: Noah Medical. Description: The Galaxy System bronchoscopic visualization device and accessories. Quantity: 47. Sold/distributed: US states listed; international distribution to Hong Kong and Australia. Recall date: 2025-09-12. Status: Active. Class: II. UDI/Code references include EOQ, 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,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed to 20 US states and Hong Kong and Australia
- Password-protected Instructions for Use/User Manual
- No reported injuries or incidents
- Active recall as of 2025-12-03
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
