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  1. Medical Device Recalls

The list below contains recalls that were issued in 2020.

2020 Medical Device Recalls

Device Name Date
Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device 12/23/20
Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues 12/01/20
Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error 11/12/20
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use 11/09/20
Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues 11/03/20
Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys 10/02/20
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes 09/16/20
Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame 09/14/20
Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys 09/14/20
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error 08/24/20
CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion 08/05/20
Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use 07/17/20
Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires 07/02/20
Endologix Inc. Recalls Ovation iX Abdominal Stent Graft Systems Due to Risks of Polymer Leaks During Implantation 06/16/20
Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures 06/01/20
Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up 05/28/20
Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use 05/12/20
Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use 04/30/20
Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment 04/07/20
LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue 04/02/20
CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion 03/30/20
Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture 03/30/20
CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion 03/18/20
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors 03/06/20
King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image 02/27/20
Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles 02/25/20
Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate 02/19/20
Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway 02/19/20
ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure 02/19/20
Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing (Updated 10/5/2021) 02/12/20
GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation 02/07/20
GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values 02/04/20
Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve 01/28/20



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