San Carlos, CA, United States
Noah Medical recalls
5 recalls recorded since 2018, most recently on 12 September 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)5
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 September 2025
- Reason
- Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0598-2026
- 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 pa
Ongoing Class II Medical devices
- Recall started
- 28 October 2024
- Reason
- Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
- Distribution
- US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0742-2025
- Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Ongoing Class II Medical devices
- Recall started
- 25 October 2024
- Reason
- Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
- Distribution
- US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0679-2025
- Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Ongoing Class II Medical devices
- Recall started
- 25 October 2024
- Reason
- Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
- Distribution
- US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0693-2025
Ongoing Class II Medical devices
- Recall started
- 9 March 2024
- Reason
- Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
- Distribution
- U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1734-2024
- Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.