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 35041–35060 of 38,428 recalls
Recalled Item: 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar...
The Issue: Synthes became aware that during a procedure using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIPELINE LS ACCESS SYSTEM
The Issue: Dilators and Holding Clip are being used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIPELINE LS ACCESS SYSTEM
The Issue: Dilators and Holding Clip are being used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIPELINE LS ACCESS SYSTEM
The Issue: Dilators and Holding Clip are being used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIPELINE LS ACCESS SYSTEM
The Issue: Dilators and Holding Clip are being used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIPELINE LS ACCESS SYSTEM
The Issue: Dilators and Holding Clip are being used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images...
The Issue: A limited number of endoscopes were shipped to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VisuALIF
The Issue: The product has the potential to be laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "***Flo Trac Sensor Model MHD85***" Sterile
The Issue: The Edwards Lifesciences FloTrac Sensor is being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific is initiating a recall removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific is initiating a recall removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow International
The Issue: Arrow is recalling the product due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: High Flow Irrigation Extender
The Issue: During arthroscopic surgery, when the scope is moved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric
The Issue: Certain lots of Trochanteric Fixation Nail were distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and
The Issue: Two lots of Titanium Trochanteric Fixation Nail (TFN)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used
The Issue: Complaints were received of inconsistencies in the expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Titanium Cannulated Humeral Nail Intended to aid in the
The Issue: The packaging incorrectly depicts the Synthes Titanium Cannulated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended
The Issue: A complaint was reported regarding a screw being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing
The Issue: The Synthes 4.5 mm LCP Curved Condylar Plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.