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 26041–26060 of 38,428 recalls
Recalled Item: Lumex
The Issue: GF Health Products, Inc., in conjunction with OKIN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PET Infusion Pump
The Issue: The Source Administration Sets (SAS) used with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8500M Handheld Pulse Oximeter
The Issue: Nonin manufactures and sells two 8500 handheld pulse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Restoris RIO Reamer Handle
The Issue: Failure of the Offset Cup Reamer Handle not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with
The Issue: The insert and case label description of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ORCHESTRA PLUS Programmer A portable device
The Issue: Sorin Group USA, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation Modules
The Issue: overheating of power cord plugs used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ORCHESTRA Programmer A portable device
The Issue: Sorin Group USA, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab Automation Modules Recalled by Siemens Healthcare Diagnostics, Inc....
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Professional Hospital Supply
The Issue: Added Instructions for Use: After application, inspect the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Devon Light Glove packaged in sterile surgical kits :
The Issue: Added Instructions for Use: After application, inspect the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended
The Issue: A complaint was received on September 27th, 2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product
The Issue: Added Instructions for Use: After application, inspect the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System The Monaco system is used to make
The Issue: When creating 3D plans using either MU or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.