Medical Devices

2014 Medical Device Recalls

The list below contains recalls that were issued in 2014.

2014 Recalls

Device NameDate
Halyard Health, KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes - Component May Detach During Use 12/31/14
Nellcor Puritan Bennett, 980 Ventilator System - Component Failure May Cause Burning Odor 12/31/14
Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs 12/24/14
Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems 12/24/14
CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs 12/03/14
Philips / Children's Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold 12/01/14
Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels - May Produce Incorrect Results 12/01/14
Baxter Healthcare Corporation, INTRAVIA Empty Containers with PVC Ports – Particles Found in Patient Solution 11/20/14
Respironics California, Esprit V1000 and V200 Ventilators - Power Failure May Occur 11/19/14
Nellcor Puritan Bennett, 980 Ventilator System - Software Issue May Stop Ventilator 11/07/14
Hospira, GemStar Power Supply, 3VDC - Power Supply for GemStar Infusion Pumps May Not Deliver Enough Electricity 11/05/14
Richard-Allan Scientific, 10% Neutral Buffered Formalin - May Contain Incorrect Concentration of Formalin 10/31/14
Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes – Electrodes will Not Work with Philips FR3 and FRx Automated External Defibrillators (AEDs) 10/21/14
CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure 10/17/14
ICU Medical, Inc., ConMed Stat2 Flow Controller – Delivers Higher Flow Rate than Intended 10/09/14
Teleflex Medical, Hudson RCI Pediatric Anesthesia Breathing Circuits - Circuit Ends May Crack or Break 10/07/14
Customed Inc., Surgical Convenience Packs - Damaged Packaging 09/05/14
Cook CloverSnare 4-Loop Vascular Retrieval Snare - Snare Tip May Break During Use 09/04/14
DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery 08/26/14
Children’s Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold 08/21/14
Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System - Sheath May Fracture During Use 08/19/14
Enhancement Medical, Expression – Hyaluronic Acid Concentration 08/14/14
Wellspring Pharmaceutical Corporation, IPM Wound Gel - Microbial Contamination 08/12/14
GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) - CO2 Detector May Fail Leading to Injury 07/25/14
Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips – Labeling Error May Lead to Use of Incorrect Glucose Meters 07/22/14
Ventlab, LLC., Ventlab Manual Resuscitator, Duckbill Valve May Stick and Prevent Air from Getting to the Patient 07/10/14
Vascular Solutions Langston V2 Dual Lumen Catheters (Models 5540 and 5550) - Inner Catheter May Separate During Use and Cause Injury 07/07/14
Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System - Patient Line Tubing May Disconnect and Lead to Injury 07/02/14
Nitinol Devices and Components, Inc., HydroFinity Hydrophilic Guidewire - May be Damaged during Use and May Lead to Injury 06/25/14
ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing 06/20/14
Smiths Medical - Portex Low Dead Space Connector with Sideport, 3.5mm 06/12/14
Fresenius NaturaLyte Liquid Bicarbonate Concentrate (Part Number: 08-4000-LB) - Bacterial Contamination 05/28/14
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs - May Detach from Nasal Tubing and Interrupt Therapy 05/23/14
Maquet Datascope Corporation, Intra-Aortic Balloon Pumps, System 98/98XT, CS100/CS100i, and CS300 - Potential Failure of Fan Assembly May Cause Pumps to Shut Down Without Any Alarm 05/22/14
Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 - Software Errors May Cause Toxic or Overdose Symptoms 05/22/14
CareFusion 303, Inc., Alaris Pump Module (Model 8100), Version 9.1.18 - Software May Not Properly Delay an Infusion with "Delay Until" Option or "Multidose" Feature 05/20/14
Alere INRatio2 PT/INR Professional Test Strips - Results Disagree with the Confirmed PT/INR Reference Test Results Performed by Central Laboratory 05/15/14
Hospira Inc., GemStar Docking Station (List Number 13075) – Potential for Error or Failure to Power Up 05/09/14
Hospira Inc., Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps - Broken Door Assemblies May Result in Over-Infusion or Delay of Therapy 05/02/14
Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB - System Error May Interrupt or Delay Therapy 05/01/14
HeartWare, Inc., Heartware Ventricular Assist System - Locking Mechanism of Pump Driveline Connector May Fail to Engage 04/29/14
Covidien, Pipeline Embolization Device and Alligator Retrieval Device - (Certain Catalog / Lot Numbers) - Coating on Delivery Wire Could Delaminate and Detach 04/21/14
Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software Defect May Cause System to Stop Working 04/16/14
Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM) - Erroneously Low Blood Glucose Results 04/11/14
Dräger Medical Inc., Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units - Battery Depletion 04/03/14
Thoratec Corporation, HeartMate II LVAS Pocket System Controller – Insufficient Labeling and Training for Patients Switched from the EPC Controller 04/01/14
McKesson Technologies, McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data 03/14/14
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL - Particulates Found in Hospira supplied 1% Lidocaine HCl 03/13/14
Greatbatch Medical, Offset Cup Impactor - Inadequate Sterilization 03/12/14
Philips Respironics, Trilogy Ventilator, Models 100, 200, and 202 - Failure to Deliver Mechanical Breaths 03/07/14
GE Healthcare, Giraffe Warmer with Resuscitation System, Panda Warmer with Resuscitation System, Giraffe Stand-Alone Infant Resuscitation System, Resuscitation System Upgrade Kits, Panda Freestanding with Resuscitation System – Issue – Oxygen and Air inlet Fittings Were Reversed During Assembly 02/28/14
Medline Industries – ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 02/25/14
Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) - Potential Kinking During Patient Use 02/24/14
Codman Neuro, TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System - Incorrect Instructions for Use 01/30/14
Tandem Diabetes Care, t:slim Insulin Cartridges (Specific Lots) - Potential for Cartridge Leak 01/10/14
Covidien, Puritan Bennett 840 Series Ventilator - Software Problem 01/09/14
Abbott Diabetes Care, FreeStyle and FreeStyle Lite Blood Glucose Test Strips - Erroneously Low Blood Glucose Results 01/06/14
GE Healthcare, LLC - Multi Absorber Original, Disposable - Model M1173310 01/06/14
Nephros Filtration Products (labeling promoting medical claims) 01/06/14
Nephros Water Filtration Products (exposure to bacteria or virus) 01/06/14

Page Last Updated: 03/05/2015
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