Noah Medical recalls Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide…
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Read the official notice →- Date
- 2024-05-08
- Country
- United States
- Brand
- Noah Medical
- Product
- Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Noah Medical recalls
- 2025-12-03
USNoah Medical Corporation recalls Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its…
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
FDA · DeviceNoah Medical CorporationUS distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN,…Official notice →- 2025-01-01
- US
Noah Medical recalls Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic…
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…
FDA · DeviceNoah MedicalUS: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NCOfficial notice → - 2024-12-25
- US
Noah Medical recalls Galaxy System (GAL-001)
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…
FDA · DeviceNoah MedicalUS: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NYOfficial notice → - 2024-12-18
- US
Noah Medical recalls Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
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…
FDA · DeviceNoah MedicalUS Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ,…Official notice →
Other drugs & medical recalls in the United States
- 2024-05-08
- US
RAYSEARCH LABORATORIES AB recalls RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Stryker Neurovascular recalls The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a…
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification…
FDA · DeviceStryker NeurovascularUS Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA,…Official notice → - US
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Panama, Guatemala,…Official notice → - US
Covidien recalls Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
FDA · DeviceCovidienUS: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI…Official notice → - US
Zimmer, Inc. recalls ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary…
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock,…
FDA · DeviceZimmer, Inc.Worldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice → - US
IVOCLAR VIVADENT AG recalls IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and…
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration