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Learn about Medical Device Recalls
What is a recall?

Who recalls medical devices?

What happens in a medical device recall?

What is a Class I recall?

What is a Class II recall?

What is a Class III recall?

Medical Device Recalls

FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

Use the list below to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The text links following each listing give details about what to do if you own or use one of these products.

Device Name Date Initiated Links
Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) 8/28/08 Text
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System 6/6/08 Text
Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) 3/17/08 Text
Class II Recall: Chattem, Inc. Icy Hot Heat Therapy Products 2/12/08 Text
Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps 1/16/08 Text
Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters 1/14/08 Text
AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) 12/20/07 Text
Cardinal Health Alaris® Infusion Pump Module (formerly Medley™ Pump Module), Model 8100 10/29/07 Text
Welch Allyn AED 10™ Automatic External Defibrillators 10/26/07 Text
Thoratec Corporation Implantable Ventricular Assist Devices (IVAD) 10/19/07 Text
Medtronic Inc. Sprint Fidelis® Defibrillator Leads 10/15/07 Text
Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank 9/8/07 Text
MRL/Welch Allyn AED 20™ Automatic External Defibrillators 8/24/07 Text
Baxter Upgraded Colleague CX Single Channel Volumetric Infusion Pumps 8/15/07 Text
Medtronic Inc. SynchroMed EL Implantable, Infusion Pump 8/3/07 Text
Baxa Corporation Exacta-Mix™ 2400 Operating Software Version 1.07 Pharmacy Compound System 6/27/07 Text
Baxter Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion Pumps (Updated August 8, 2007) 6/21/07 Text
Baxter Healthcare Corp. Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps 6/20/07 Text
Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver 6/8/07 Text
Bayer Ascensia® Contour® Blood Glucose Monitoring System 6/6/07 Text
Advanced Medical Optics, Inc. COMPLETE® MoisturePLUS™ Multi-purpose Contact Lens Solution 5/25/07 Text
Integra LifeSciences Corporation (also known as Integra NeuroSciences) EnDura™ No-React® Dural Substitute 5/4/07 Text
Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products Troponin I Reagent Pack 4/27/07 Text
Sunrise Medical Quickie® Power Wheelchairs 4/23/07 Text
Thoratec® Paracorporeal Ventricular Assist System (PVAD) 3/30/07 Text
Abbott Laboratories Inc. ARCHITECT® STAT Troponin-I Immunoassay 3/8/07 Text
Alcon Refractive Horizons, Inc. LADAR6000 (TM) Excimer Laser System 2/21/07 Text
LifeLine® Semi-Automatic External Defibrillators (AEDs) and ReviveR® Semi-Automatic External Defibrillators (AEDs) 2/17/07 Text
HoMedics® Thera-P® Heating Pads 2/9/07 Text
Smith & Nephew, Inc. Radiofrequency Denervation Probes 1/19/07 Text
Counterfeit OneTouch® Ultra® Blood Glucose Test Strips 10/13/06 Text
Counterfeit OneTouch® Basic®/Profile® Blood Glucose Test Strips 10/10/06 Text
Cardinal Health Alaris ® SE Infusion Pumps 8/10/06 Text
Medtronic Intrathecal Catheter, Model 8731 and Intrathecal Catheter Distal Revision Kit, Model 8598 7/21/06 Text
Disetronic D-TRONplus Insulin Infusion Pump Power Packs 7/13/06 Text
Welch Allyn PIC 50™ Automated External Defibrillators 6/30/06 Text
Welch Allyn AED 20™ Automated External Defibrillators 6/15/06 Text
Medtronic SynchroMed EL Programmable Infusion Pumps 6/6/06 Text
Disetronic/Roche Diagnostics Accu-Chek™ Ultraflex-1 Infusion Set 3/31/06 Text
Ortho-Clinical Diagnostics VITROS® Immunodiagnostic Products Signal Reagent 3/28/06 Text
Respironics PLV Continuum Ventilator (PLVC I) 3/20/06 Text
The First Years® Liquid-Filled Teething Rings 1/25/06 Text
Blackstone Medical, Inc. ICON® Modular Spinal Fixation System 12/23/05 Text
Bard® Composix® Kugel® Mesh Patch - Expansion 12/22/05 Text
Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit 12/15/05 Text
Baxter Healthcare Corp. COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps 12/13/05 Text
Boston Scientific Flextome® Cutting Balloon Systems 12/7/05 Text
Boston Scientific Stainless Steel Greenfield® Vena Cava Filters 12/2/05 Text
Vapotherm, Inc. Vapotherm® 2000i and 2000h Respiratory Gas Humidifier 10/13/05 Text
Baxter Meridian® Hemodialyis (HD) Instrument 9/28/05 Text
Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps 9/19/05 Text
bioMérieux, Inc. VeriCal® Calibrator Sets 8/19/05 Text
Gambro Renal Products Prisma® Continuous Renal Replacement System 8/16/05 Text
Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps 7/19/05 Text
Guidant Corp. Pacemakers 7/18/05 Text
Ventak PRIZM 2 DR ICDs 6/29/05 Text
Boston Scientific Hemashield® VANTAGE™ Vascular Grafts 6/27/05 Text
Vail Products, Inc. Enclosed Bed Systems 6/24/05 Text
Abbott Blood Glucose Meters 6/7/05 Text
Laerdal Medical Corp. CM 100 Heartstart® Automatic External Defibrillator Adapter Cables 4/29/05 Text
Welch Allyn Co., AED 20®, Automatic External Defibrillator 4/28/05 Text
LifeScan, Inc. Blood Glucose Meters 4/11/05 Text
BioMerieux Simplastin HTF Tissue Reagent 3/7/05 Text
HeartSine Technologies, Inc. Automatic External Defibrillators 2/14/05 Text
MicroScan® Rapid Pos Inoculum Broth 2/7/05 Text
Certain Medtronic LIFEPAK 500 Automated External Defibrillators 2/5/05 Text
IV Flush Heparin and Saline IV Catheter Flushes 1/26/05 Text
Becton Dickinson ProbeTec ET Urine Processing Kit 1/10/05 Text
BioMed Unomedical Airway Adapter 12/2/04 Text
Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor 11/19/04 Text
Access CardioSystems Automated External Defibrillators 11/3/04 Text
Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills 10/27/04 Text
Pulmonetic Systems LTV Series of Ventilators 9/8/04 Text
Medtronic 8870 Software Application Card Version AAA 02 8/24/04 Text
Nellcor CapnoProbe Sublingual Sensor 8/24/04 Text
Medibo Minerva Patient Lifts 8/4/04 Text
Boston Scientific Express2TM (bare metal) Coronary Stent 7/16/04 Text
Shiley Tracheosoft Tracheostomy Tube and Disposable Inner Cannula 7/8/04 Text
Boston Scientific Taxus™ Express2TM (paclitaxel-eluting) Coronary Stent 7/1/04 Text
Arjo Alenti Lift Hygiene Chair 6/8/04 Text
Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack 6/7/04 Text
Carl Zeiss Meditec Ophthalmic System 6/3/04 Text
Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers 5/24/04 Text
Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation 5/5/04 Text
Roche Diagnostics Tecan Clinical Workstation 5/5/04 Text
PRECISE® RX Nitinol Stent Transhepatic Biliary System 5/4/04 Text
Tecan Clinical Workstation with RoboNet Software 5/3/04 Text
Arjo MINSTREL Patient Lifts 4/30/04 Text
VITEK GPS-107 Cards (Additional Lot) 4/20/04 Text
Micro Jewel II and GEM DR ICDs (implantable cardioverter-defibrillators) 4/4/04 Text
Roche Diagnostics Tecan Clinical Workstation 3/5/04 Text
MiniMed Paradigm Quick-set Plus Insulin Administration Set 3/2/04 Text
VITEK GPS-107 Cards 1/28/04 Text
Faaborg Patient Lifts 1/21/04 Text
ComfortGel Nasal Masks 9/29/03 Text
CoaguChek PT Test Strips 9/12/03 Text
Laboratory Information System Software Device, version 5.3 8/12/03 Text
VIDAS Chlamydia Assay 8/6/03 Text
ProbeTec ™ ET Instrument 7/21/03 Text
Tosoh Bioscience AIA-600 II Analyzers 4/2/03 Text
Portex Resuscitator 11/15/02 Text
Baxter Intravenous Filter Sets 10/17/02 Text
CAPTIA Syphilis G Elisa Test Kit 7/22/02 Text
Disetronic D-TRON Insulin Infusion Pump 6/17/02 Text
Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800 6/3/02 Text
Bassinets with drop leaf work surface, models 248 and 1251 3/20/02 Text
Class 1 Medical Device Recall: Infant Bassinet 3/20/02 Text
Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800 3/12/02 Text
Bard RapidFire Multiple Band Ligator (Item No. 000608) 1/31/02 Text
Solar 9500 Physiological ECG Monitor 7/20/01 Text
ESPRIT Ventilator 6/8/01 Text
Adcon-L and Adcon-T/N sterile 1/19/01 Text
Puritan-Bennett Ventilator, Model 840 containing Revision E-level software 12/22/00 Text
Gelfoam Sterile Power and Sponge 11/17/00 Text

Updated September 11, 2008

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