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 20661–20680 of 38,428 recalls
Recalled Item: Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with...
The Issue: Medtronic has become aware of a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The...
The Issue: Medtronic has become aware of a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with...
The Issue: Medtronic has become aware of a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with...
The Issue: Medtronic has become aware of a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with...
The Issue: Medtronic has become aware of a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percepta CRT-P MRI SureScan
The Issue: for a device reset to occur in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The...
The Issue: Medtronic has become aware of a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5
The Issue: Label was incorrect. The label states that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Maestro 4000 Cardiac Ablation System
The Issue: Reports of unintended continuation of radiofrequency (RF) energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Tri-Flo Subglottic Suction System
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic
The Issue: Through investigation, it was determined that H12LP Trocars
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnastoClip GC Closure System
The Issue: The wrong instructions for use (IFU) were supplied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NICO Shepherd' s Hook - Greenberg
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J-Plasma Precise 360
The Issue: There is a potential risk associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPAP Mask Cushion
The Issue: A May 2015 design change in the cushion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Bolt
The Issue: Product was manufactured from the incorrect material, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Slit Knife 2.6mm 45degree Bevel Up
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Oasis MRI system Product Usage: Hitachi MR system is
The Issue: The stainless steel belt which runs the length
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRINIAS Digital Angiographic System intended to be used for cardiac angiography
The Issue: Due to a software issue the C-arm may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.