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 13081–13100 of 38,428 recalls
Recalled Item: Drill Bit
The Issue: The color indicator on the proximal end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips CT systems are advanced continuous-rotation computed tomography...
The Issue: Philips has internally detected an issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Midline Catheter Dressing Change Kit with Statlock - Product Usage:
The Issue: Evidence of face masks or other material in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 4.5
The Issue: For some LINAC types, merging clinical beams with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter...
The Issue: AngioDynamics, Inc. is recalling a specific batch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI
The Issue: AngioDynamics, Inc. is recalling a specific batch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter
The Issue: It has been identified that the catheter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually
The Issue: Globally the company is removing 37 lots affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter
The Issue: It has been identified that the catheter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product
The Issue: Globally the company is removing 37 lots affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter
The Issue: It has been identified that the catheter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee
The Issue: Globally the company is removing 37 lots affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter
The Issue: It has been identified that the catheter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter
The Issue: It has been identified that the catheter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter
The Issue: It has been identified that the catheter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIROS D-Vial Prep Set
The Issue: There is a potential presence of particulate matter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2.
The Issue: BeneVision DMS may intermittently freeze and require a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT Computed Tomography X-ray System Model: 728143
The Issue: Actuators in the Incisive gantry could result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Robot UR5 arm
The Issue: Malfunction of the robotic arm preventing further movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
The Issue: Potentially defective Chip Cassette units, when used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.