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 11361–11380 of 38,428 recalls
Recalled Item: Instructions for Use for all model numbers of the Medtronic
The Issue: There have been reports of stent migration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa Direct Amplification Disc Kit
The Issue: A subset of affected discs are at risk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper FD series with Software Version Number: 2.1.x-
The Issue: Set screws securing the two gliding rods of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated
The Issue: (1)Software (SW) versions V1.25.1 and lower may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES HSV 1&2 Assay
The Issue: Impacted lot may leak inside the ARIES instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malosa Core SMILE Pack 1-Medical Kit intended to be
The Issue: Kit packaging may have small holes compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malosa Core LASIK Pack 2-Medical Kit- intended to be
The Issue: Kit packaging may have small holes compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Senior Living Arial Emergency and Nurse Call Systems
The Issue: Systems are not alarming due to increased memory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be
The Issue: Kit packaging may have small holes compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malosa Core Phaco Pack 2- Medical Kit intended to
The Issue: Kit packaging may have small holes compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DYNANAIL MINI
The Issue: The firm identified a nonconformance in Lot 04882
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Kit intended
The Issue: Kit packaging may have small holes compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to
The Issue: Kit packaging may have small holes compromising product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas LiatSystem
The Issue: Roche has identified a small number of cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instavac Portable Suction Pump
The Issue: Increase in premature device failures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
The Issue: As a result of a manufacturing error, one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75
The Issue: Firm is initiating a correction due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31
The Issue: Firm is initiating a correction due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
The Issue: Due to a calculation error in the measurement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with
The Issue: (1)Start-up problem: Intermittently at start-up of the system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.