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 23861–23880 of 38,428 recalls
Recalled Item: EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer
The Issue: Instructions for use (IFU) is updated to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #:
The Issue: Instructions for use (IFU) is updated to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38
The Issue: Instructions for use (IFU) is updated to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #:
The Issue: Instructions for use (IFU) is updated to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Logic Fit Tibial Tamp Head
The Issue: The firm determined that the labeling (surgical technique)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX-Revolution Mobile X-Ray System
The Issue: Carestream found a single unit where four screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrohydraulic lithotripter probe
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Samsung GU60A system- Digital X-ray Imaging Systems are intended for
The Issue: When performing the Stitching function on GU60A system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge OrthoPACS software.
The Issue: A migrated study that has annotations will display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge OrthoPACS software. The firm name on the label is Merge Healthcare
The Issue: Studies that have QC, PDE, or HL7 ADT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM
The Issue: The device collar size was incorrectly labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Protein 1 Control M
The Issue: Complaint of high amount of ceruloplasmin patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Protein 1 Control H
The Issue: Complaint of high amount of ceruloplasmin patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Protein 1 Calibrator
The Issue: Complaint of high amount of ceruloplasmin patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Protein 1 Control
The Issue: Complaint of high amount of ceruloplasmin patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Video Gastroscope
The Issue: Error in reprocessing instructions in Revisions 13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Video Gastroscope
The Issue: Error in reprocessing instructions in Revisions 13 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leksell Gamma Knife Icon is a teletherapy device intended for
The Issue: If the gantry module is replaced after original
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM
The Issue: The device collar size was incorrectly labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro
The Issue: Cracks may occur over time on the tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.