FDA Medical Device Recalls (openFDA)
Noah Medical Corporation: 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.
- Recall number
- Z-0598-2026
- Recalling firm
- Noah Medical Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2025-09-12
- Posted
- 2025-11-26
- Terminated
- not on file
- Reason
- Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
- Root cause
- Under Investigation by firm
- Action
- On 09/12/2025, the firm sent via FedEx an "Urgent: MEDICAL DEVICE RECALL" Letter to customers. The letter described the product, risk to health and action to be taken. Customers were notified that the password has been removed and they are instructed to: Log in and access the applicable IFU and all addendums. Noah Medical recommends that customers download the IFU and addendums for ease of reference. For questions contact: Noah Medical Customer Service email: customerservice@noahmed.com Noah hotline: 888-325-NOAH (1-888-325-6624)
- Quantity
- 47
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K223144"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3021325287
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28