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Medical Devices

2013 Medical Device Recalls

The list below contains recalls that were issued in 2013.

2013 Medical Device Recalls

Listed by date posted on the FDA Website

Device NameDate
Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits - Bag-to-Vent Switch in CAS I/II Absorbers May Fail [ARCHIVED] 11/26/13
Hospira Inc., GemStar Infusion System - Pressure Sensor Calibration Drift [ARCHIVED] 11/25/13
Medtronic Interventional Guidewires and ATTAIN HYBRID® Guidewires [ARCHIVED] 11/19/13
Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test - Marketing Without Approval or Clearance [ARCHIVED] 11/12/13
Pentax Medical Company, PENTAX Gas/Water Valve, Model OF-B194 [ARCHIVED] 11/08/13
Baylis Medical TorFlex Transseptal Guiding Sheath Kit [ARCHIVED] 11/06/13
Edwards Lifesciences LLC, EMBOL-X Glide Protection System [ARCHIVED] 11/04/13
Draeger Medical Fabius Series Anesthesia Machines - Failure of Automatic Ventilation [ARCHIVED] 10/23/13
Codman and Shurtleff MedStream Programmable Infusion Pump and Refill Kits - Drug Over Infusion [ARCHIVED] 10/23/13
GE Healthcare – Engström Ventilator and Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines [ARCHIVED] 10/22/13
CareFusion 211, Inc., AVEA Ventilators, All Models [ARCHIVED] 10/21/13
H and H Medical Corporation (formerly H and H Associates) Emergency Cricothyrotomy Kit – Cuff Balloon May Not Function as Intended [ARCHIVED] 10/21/13
Bard LifeStent Solo Vascular Stent - Failure to Deploy Stent [ARCHIVED] 10/18/13
Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels [ARCHIVED] 09/12/13
Stryker Spine - OASYS Midline Occiput Plate [ARCHIVED] 08/29/13
Hospira Intravascular Administration Sets [ARCHIVED] 08/14/13
Nova Biomedical Corporation, Specified Lots of Nova Max Glucose Test Strips [ARCHIVED] 08/13/13
Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit [ARCHIVED] 08/12/13
Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter [ARCHIVED] 08/08/13
CareFusion – Alaris PC unit (model 8015) with version 9.12 Keyboard Processor [ARCHIVED] 08/07/13
DePuy Orthopaedics, Inc - LPS Lower Extremity Dovetail Intercalary Component [ARCHIVED] 08/01/13
GE Healthcare Nuclear Medicine Systems [ARCHIVED] 07/29/13
LeMaitre Vascular, Inc., Albograft Vascular Graft [ARCHIVED] 07/24/13
MedStream Programmable Infusion Pump [ARCHIVED] 07/23/13
Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube - Mislabeling [ARCHIVED] 07/22/13
Medtronic MiniMed Paradigm Insulin Infusion [ARCHIVED] 07/12/13
Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades [ARCHIVED] 07/10/13
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Feed Through Failure [ARCHIVED] 06/28/13
Medtronic Sutureless Connector Intrathecal Catheter Products – Catheter Occlusion [ARCHIVED] 06/28/13
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Failure of Priming Bolus [ARCHIVED] 06/28/13
Medtronic Xomed, Inc., NIM Trivantage EMG Endotracheal Tube [ARCHIVED] 06/21/13
Respironics California, Inc., V60 Ventilators [ARCHIVED] 06/20/13
Endologix, Inc., AFX Introducer System [ARCHIVED] 06/18/13
Symbios GOPump and GOBlock Kits [ARCHIVED] 06/12/13
Nephron Pharmaceuticals Corporation – EZ Breathe Atomizer [ARCHIVED] 06/03/13
Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent [ARCHIVED] 05/24/13
Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters [ARCHIVED] 05/20/13
Maquet SERVO-i Ventilator Battery Module [ARCHIVED] 05/07/13
Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit [ARCHIVED] 05/07/13
Cardinal Health – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit [ARCHIVED] 05/07/13
Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators [ARCHIVED] 05/01/13
Hospira Inc., GemStar Infusion System - Damage from Battery Leakage [ARCHIVED] 05/01/13
Hospira Inc., GemStar Infusion System, Lithium Battery - Low Voltage [ARCHIVED] 04/29/13
Engineered Medical Systems, Inc., SealFlex Single Port Ribbed Mask (Infant) [ARCHIVED] 04/24/13
GE Healthcare, Giraffe OmniBed and Giraffe Incubator [ARCHIVED] 04/24/13
LifeScan, Inc., OneTouch Verio IQ Blood Glucose Meter [ARCHIVED] 04/23/13
CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12 [ARCHIVED] 04/22/13
Stryker Orthopaedics – ShapeMatch Cutting Guide [ARCHIVED] 04/18/13
Animas Corporation 2020 Insulin Infusion Pump [ARCHIVED] 04/05/13
Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves, Model Numbers 8210, 8211, 8215, and 8216 [ARCHIVED] 03/27/13
Spacelabs Medical, Inc., Spacelabs Anesthesia Workstations and Service Kits [ARCHIVED] 03/26/13
Symbios Medical Products, LLC, GOPump Elastomeric Infusion PumpKit, Part Number 510076 [ARCHIVED] 03/18/13
Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes [ARCHIVED] 03/07/13
Lumenis Limited, Lumenis VersaCut Tissue Morcellator [ARCHIVED] 02/25/13
DePuy Orthopaedics, Inc – LPS Diaphyseal Sleeve [ARCHIVED] 02/22/13
GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems [ARCHIVED] 02/14/13
St. Jude Medical, AMPLATZER TorqVue FX Delivery System [ARCHIVED] 02/12/13
Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower [ARCHIVED] 02/07/13
Vycor Medical, Inc., Vycor Viewsite Brain Access System (VBAS) [ARCHIVED] 01/30/13
Bausch and Lomb 27G Sterile Cannula Packed in Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Ophthalmic Viscosurgical Device [ARCHIVED] 01/23/13
Fisher and Paykel Healthcare – Reusable Breathing Circuit [ARCHIVED] 01/07/13
Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units [ARCHIVED] 01/02/13

Page Last Updated: 07/09/2015
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