FDA Medical devices recall ·
Galaxy System Product Name: Galaxy System Model recall
- Recall number
- Z-0598-2026
- Date
- (initiated September 12, 2025)
- Company / brand
- Noah Medical
2075 Zanker Rd, San Jose, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 47
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
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
States: California Colorado Idaho Illinois Indiana Massachusetts Maryland Minnesota Missouri North Carolina New Jersey New York Ohio Pennsylvania South Carolina Tennessee Virginia Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0598-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.