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 19841–19860 of 38,428 recalls
Recalled Item: Genicon GENILook Model 200-105-252
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-105-251
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-105-152
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon Natura Model 210-005-052
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts
The Issue: ParaPost Plus Titanium Posts contain stainless steel post
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Dual Lumen Cannula
The Issue: These catheters may have the following deficiencies: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Dual Lumen Cannula
The Issue: These catheters may have the following deficiencies: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Dual Lumen Cannula
The Issue: The catheter failed the endotoxin testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Dual Lumen Cannula
The Issue: These catheters may have the following deficiencies: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Dual Lumen Cannula
The Issue: These catheters may have the following deficiencies: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: These catheters may have the following deficiencies: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Dual Lumen Cannula
The Issue: These catheters may have the following deficiencies: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Reverse Drill Bit Kit
The Issue: The Equinoxe Reverse Drill Bit Kits may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam
The Issue: Reports have been received of an anomaly that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical 14" (36 cm) Appx 3.6 ml
The Issue: Design change implemented changing the device from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy
The Issue: Reports have been received of an anomaly that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: fMRI Hardware System VisualSystem allows video signals from the stimulus
The Issue: Complaints of this version of the power supply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EEA Circular Stapler with Tri-Staple Technology
The Issue: The firm identified the potential for a device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioMend Extend
The Issue: There is a possibility that the product was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DxTerity(TM) TRA 5F
The Issue: Medtronic has determined that the French size indicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.