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 27141–27160 of 38,428 recalls
Recalled Item: The System 83 Plus
The Issue: To warn customers that Custom Ultrasonics, Inc. System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ariol is an automated scanning microscope and image analysis system.
The Issue: An issue during the manufacturing process caused systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Enzyme II Calibrator is an in vitro diagnostic product
The Issue: Complaints of positive shift of patient and QC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Enzyme 2 Calibrator is an in vitro diagnostic product
The Issue: Complaints of positive shift of patient and QC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Sheridan/HVT Cuffed
The Issue: The labeling of some units indicates that it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker PowerPRO (XT
The Issue: Complaints of smoke coming from the foot end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser
The Issue: Failure to provide the required instructions specifying a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical
The Issue: Failure to provide the required instructions specifying a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tearaway Introducer
The Issue: This recall has been initiated due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReShape Integrated Dual Balloon System
The Issue: Due to a suspected misalignment of the connection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
The Issue: Inability to deploy the stent or partial stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
The Issue: Inability to deploy the stent or partial stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac Vero is a Patient Positioning System for Radiation therapy.
The Issue: Potentially incorrect positioning when using Implanted Marker Detection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II
The Issue: Complaints were received for the Stryker FlowPort II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaFx Femoral Fixation System Hex head compression screw 4.7 mm
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herbert Cannulated Bone Screw System
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.