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 11701–11720 of 38,428 recalls
Recalled Item: Medtronic sterile single-use blades that are components of the StraightShot
The Issue: There was an increase in complaints related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic sterile single-use blades that are components of the StraightShot
The Issue: There was an increase in complaints related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoraguard Chest Tube Kit
The Issue: An adhesive joint in the SmartValve component of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force with software syngo.CT VB20 Model #10742326
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Confidence with software syngo.CT VB20 Model #10590100
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Drive with software syngo.CT VB20 Model #10431700
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
The Issue: software syngo.CT VB20 in the installed base, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK LOGIC Polyethylene Tibial Inserts
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components.
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRULIANT Knee System including TRULIANT Tibial Inserts
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Comprehensive Knee System custom devices labeled as the following:
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Comprehensive Knee System
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI...
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial
The Issue: Inserts were packaged in vacuum bags that lacked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software BeamAdjust version 2.2
The Issue: When a measurement with a PTW detector array
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.