Reported Dec 3, 2025 · Ongoing

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy…

Noah Medical Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Noah Medical Corporation · 2075 Zanker Rd · San Jose, CA · 95131-2107

Brand NameGalaxy
System Product NameGalaxy
System Model/Catalog NumberGAL-001
Product DescriptionThe Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure

Lot codes and dates: Lot CodeProduct
CodeEOQ
UDI00850048825048
SNincluded 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
Amount recalled: 47

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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