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2019 Medical Device Recalls

2019 Medical Device Recalls

The list below contains recalls that were issued in 2019.

2019 Medical Device Recalls

Device Name Date
Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of Inaccurate Results 05/23/19
Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples 05/16/19
Alpha Omega Engineering Recalls Neuro Omega System Due to Design Flaw Which May Cause Significant Tissue Harm 05/06/19
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

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