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 32881–32900 of 38,428 recalls
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and...
The Issue: Additional caution statements have been added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KODAK DirectView DR 9000 System
The Issue: A control system failure may cause the U-Arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ Systems TnI-Ultra assay
The Issue: The solid phase reagent in some of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage BNP Calibrators for the Beckman Coulter Access Family
The Issue: Alere San Diego is recalling Alere Triage BNP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Guide Blocks for the 2 Column Plate 6 Hole
The Issue: The Guide Blocks for the 2 Column Plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR
The Issue: Complaints were received that reported the stopcock of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ MOSAIQ is an oncology information system used to manage
The Issue: MOSAIQ does not re-calculate the agent volume when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tytin Regular Set
The Issue: Kerr Corporation is recalling one (1) lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iGUIDE System Product Usage: The intended use of the device
The Issue: A bug in the software prevents the iGUIDE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon Medical Imaging Horizon Medical Imaging is a medical image
The Issue: Firm received a complaint that an unreported study
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VTI BAYONET DOPPLER
The Issue: Report of the product penetrating the sterile barrier;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.