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 2381–2400 of 38,428 recalls
Recalled Item: GALT Centeze Catheter DRC-002-06 The Centeze is intended
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
The Issue: The mounting hardware that is supplied with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
The Issue: When DxI 9000 Access Immunoassay Analyzer is connected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Trimble RTS873 robotic total station is a solution designed
The Issue: An issue has been identified in the production
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP.
The Issue: The hip cup liner that was packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella
The Issue: It was determined that there could be a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Explorer/Nova Dual
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Master/Nova
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 3.0T
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 1.5T
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.0T Omni/Stellar
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enterprise 1.5T
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Omni/Stellar
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 0.5T Standard
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 3.0T Quasar Dual
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Power/Pulsar
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T R11
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.0T Power/Pulsar
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera CV
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.