Medical Devices

2016 Medical Device Recalls

The list below contains recalls that were issued in 2016.

2016 Recalls

Device NameDate
Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization 12/16/16
Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate 12/09/16
Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating 11/30/16
SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation 11/22/16
HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connector Ports 11/16/16
HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues 11/16/16
Customer Letter for the Class II Teleflex LMA Mucosal Atomization Devices. (PDF - 76KB) 11/09/16
St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion 10/24/16
TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use 10/20/16
Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10 10/14/16
Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination 10/06/16
DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk 09/28/16
Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination 09/06/16
Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results 08/25/16
BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS® easyMAG® Magnetic Silica for Nucleic Acid Extraction 08/12/16
Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage 08/04/16
CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown 07/28/16
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation 07/22/16
HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion 06/29/16
Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk 05/27/16
Hummingbird Med Devices Inc. Recalls Hummi Micro-Draw Blood Transfer Device Due to Potential for Parts to Disconnect 05/26/16
B. Braun Medical Inc. Recalls Dialog+ Hemodialysis Systems Due Defective Conductivity Sensors 05/04/16
Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage 04/19/16
Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect 04/13/16
Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results 04/13/16
Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure 04/11/16
Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate 03/30/16
Verathon Inc. Recalls GlideScope Titanium Single-Use Video Laryngoscope Due to Potential Video Feed Disruption 03/18/16
Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue 03/17/16
Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process 03/15/16
Dräger Evita V500 and Babylog VN500 Ventilators - Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware 03/03/16
Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots 02/25/16
Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy 02/10/16
Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings 01/28/16
Thornhill Research Inc. Recalls MOVES Ventilator System Due to Battery Problem 01/27/16
St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads Due to Damage that May Prevent Patient Therapy 01/26/16
Brainlab Cranial Image-Guided Surgery (IGS) System - Navigation Inaccuracy 01/15/16
Stryker Fuhrman Pleural and Pneumopericardial Drainage Sets - Catheter May Break During Insertion 01/11/16
Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly 01/05/16

Page Last Updated: 01/03/2017
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