2019 Medical Device Recalls

05/05/2019


Overall medical device recalls have increased substantially in the last ten years. According to a recent U.S. Food and Drug Administration report, recalls of medical devices doubled from 2003 to 2012 (they went from 604 to 1,190.)  

Here is the list of recalls to date for 2019:

  • Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters Due to Balloon Deflation, Fragmentation and Detachment Issue 04/26/19 
  • Brainlab AG Recalls Spine & Trauma 3D Navigation Due to Inaccurate Display That May Result in User Misinterpretation 04/15/19 
  • O-Two Medical Technologies, Inc. Recalls o_two e700, e600 and e500 Automatic Transport Ventilators Due to Potential Risk of Fire 04/03/19 
  • Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments 03/18/19 
  • RVO 2.0, Inc. Recalls Raindrop Near Vision Inlay Due to Risk of Increased Risk of Corneal Haze 03/05/19 
  • Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing) 02/27/19 
  • Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error 02/22/19 
  • Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens 02/15/19 
  • Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers 02/05/19 
  • Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results 02/04/19 
  • West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions 02/01/19 
  • Draeger Medical Recalls Breathing Circuits and Anesthesia Sets 01/25/19 
  • Medtronic Recalls Synergy Cranial Software and Stealth Station S7 Cranial Software Due to Inaccuracies Displayed During Surgical Procedures 01/08/19 


https://www.fda.gov/medical-devices/medical-device-recalls/2019-medical-device-recalls