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 6261–6280 of 38,428 recalls
Recalled Item: USTAR II Knee System : Cemented Curved Stem
The Issue: Their is a potential that the implant curved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: USTAR II Hip System Press-Fit Curved Stem
The Issue: Their is a potential that the implant curved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse Cardiology PACS V7.3.0
The Issue: The LV Mass (2D Bullet) equation may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse CV 6. with AR. A web-based application as the
The Issue: The LV Mass (2D Bullet) equation may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence
The Issue: One lot of the Sofia 2 Flu +
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. HeartMate Touch Communication System
The Issue: Due to software and controller systems that results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurovascular embolization device. The Optima Coil System is a series
The Issue: Discoloration was identified along the delivery pusher which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Prestige Coil System is a product family of embolic
The Issue: Discoloration was identified along the delivery pusher which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T CX. Model (REF) Numbers 781271
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T. Model (REF) Numbers 781196
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva XR. Model (REF) Numbers 781153
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Initial system. Model (REF) Numbers 781178.
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T CX. Model (REF) Numbers 781262
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T. Model. (REF) Numbers 781277
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Conversion. Model (REF) Numbers 781346
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 Achieva Nova-Dual. Model (REF) Number 781173.
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. Model (REF) Numbers 781260
The Issue: The Quadrature Body Coil (QBC) seal adhesive may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.