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 8421–8440 of 38,428 recalls
Recalled Item: TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number:
The Issue: for Incorrect Image Orientation resulting images may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number:
The Issue: for Incorrect Image Orientation resulting images may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model
The Issue: for Incorrect Image Orientation resulting images may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model
The Issue: for Incorrect Image Orientation resulting images may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat
The Issue: The product contains an expired diluent vial. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultraview SL (UVSL) Command Module
The Issue: Command modules will display the following when parameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation Cranial Software
The Issue: During non-axial/some axial exams, software anomalies occur during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation Cranial Software
The Issue: In nonaxial/some axial exams if surgical plan utilized,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Cranial Hand Drill- Indicated when a craniotomy is required
The Issue: Released with discoloration (rust) on the Drill Chuck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Mission Disposable Core Biopsy Instrument Kit:
The Issue: Coaxial cannula internal diameter and length of biopsy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining
The Issue: The Hard Line Chairside Reline Kit (570-0718) (0921940HS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Over-Head Ceiling Tube Support
The Issue: Eight fixing bolts at the base of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reliance Vision Multi-Chamber Washer/Disinfector
The Issue: In the remote occurrence in which the electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker ORTHOLOC 3Di Fusion Plate MTP Right
The Issue: Two lots of Ortholoc 3Di Fusion plates contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker ORTHOLOC 3Di Fusion Plate MTP Right
The Issue: Two lots of Ortholoc 3Di Fusion plates contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring...
The Issue: Irregular core patterns could cause potential overlap of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray
The Issue: There were reports from customers that the tracheostomy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set
The Issue: There were reports from customers that the tracheostomy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metal Tray
The Issue: Metal sterilization trays used to encase and protect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.