Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 4501–4520 of 38,428 recalls
Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray System with Software...
The Issue: Loss of Imaging (X-ray) Functionality and/or Longer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: Ground screws on Dxl 9000 PCB boards may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aespire 7100
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aisys CS2. This anesthesia gas machine is intended to provide
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aisys CS2 with Et Control. This anesthesia gas machine is
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aespire 100. This anesthesia gas machine is intended to provide
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avance CS2 and Avance CS2 Pro. These anesthesia gas machines
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aisys. This anesthesia gas machine is intended to provide general
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avance. This anesthesia gas machine is intended to provide general
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amingo. OUS only.
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aespire 7900. This anesthesia gas machine is intended to provide
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aespire View. This anesthesia gas machine is intended to provide
The Issue: issue that may arise if the limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ion Endoluminal System
The Issue: There is a potential that the robotic system's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Proteus XR/a
The Issue: The XR system, Proteus XR/a, does not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RMU-2000 Automated Chest Compression Device
The Issue: Problem in the device's motor may cause the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NavaClick Syringe and Needle
The Issue: Incorrect GTIN number on carton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090
The Issue: Medtronic CareLink 2090 programmers with serial number prefixes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.