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 11581–11600 of 38,428 recalls
Recalled Item: LEEP PRECISION Integrated System
The Issue: Coagulate function may not operate with the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
The Issue: Coagulate function may not operate with the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
The Issue: Coagulate function may not operate with the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemodialysis Delivery System
The Issue: If the operator initiates therapy with a saved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Ablation Catheter with Thermosphere Technology...
The Issue: The firm identified an error in the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexor Check-Flo Introducer - Raabe Modification
The Issue: Affected lots may be manufactured incorrectly with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexor Check-Flo Introducer
The Issue: Affected lots may be manufactured incorrectly with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer
The Issue: Ancillary reagent packs used on Atellica IM 1300
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer
The Issue: Ancillary reagent packs used on Atellica IM 1300
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro
The Issue: There is a risk that the Diode D1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES
The Issue: All lots of the glove may discolor and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardioblate CryoFlex Surgical Ablation Console
The Issue: There is potential for intermittent electrical connectivity between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton.
The Issue: Holes in product packaging impacts package integrity and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
The Issue: 3D-RA is a reconstruction software product that can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Permobil TiLite
The Issue: Some affected wheelchairs, with transit tie downs, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion Interventional Fluoroscopic X-Ray System
The Issue: When the user presses or releases both the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zeego
The Issue: Software error, the software can produce an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect
The Issue: Packaged dental implant contains a different size then
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect
The Issue: Packaged dental implant contains a different size then
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clinician Programmer Application (CPA) model A610 Clinician Software Application
The Issue: A software anomaly may occur with the clinician
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.