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 12101–12120 of 38,428 recalls
Recalled Item: Revolution Apex
The Issue: The accumulated dose is incorrectly displayed in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT
The Issue: The accumulated dose is incorrectly displayed in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography Systems Revolution CT
The Issue: The accumulated dose is incorrectly displayed in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Models with SW version VD12 listed below: Artis zee
The Issue: Due to a software error, the IAS (Image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation...
The Issue: The screw cover at the tip of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super
The Issue: Thermal injury following dusting and fragmenting treatment of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxygen Sensor Model K54019-2 used in the: G185 & G210
The Issue: Units are displaying output readings that differ from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude SNAP Splittable Sheath Introducer
The Issue: There is a potential that 7F sheaths are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude SNAP Splittable Sheath Introducer
The Issue: There is a potential that 7F sheaths are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sharesource Connectivity Platform for Use with the Amia Automated PD System
The Issue: Baxter Healthcare Corporation has identified that the AMIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kaguya Automated Peritoneal Dialysis System
The Issue: Baxter Healthcare Corporation has identified that the AMIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The system is intended to produce cross-sectional images of the
The Issue: When adding one or more intended scan groups
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The system is intended to produce cross-sectional images of the
The Issue: When adding one or more intended scan groups
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The system is intended to produce cross-sectional images of the
The Issue: When adding one or more intended scan groups
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with
The Issue: Weld failure- the bracket attaches the tabletop tilting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech BIOLOX delta Femoral Head
The Issue: Biolox Delta Femoral Head was packaged and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech BIOLOX delta Femoral Head
The Issue: Biolox Delta Femoral Head was packaged and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Connexion GXL acetabular polyethylene liners used in the following
The Issue: Risk of edge-loading and premature prosthesis wear is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Connexion GXL acetabular polyethylene liners used in the following
The Issue: Risk of edge-loading and premature prosthesis wear is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Connexion GXL acetabular polyethylene liners used in the following
The Issue: Risk of edge-loading and premature prosthesis wear is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.