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.
Device Name |
Date Initiated |
Links |
Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD) |
10/29/08 |
|
Stryker Leibinger USA., Stryker Custom Cranial Implant Kits |
10/24/08 |
|
Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-Gauge |
10/9/08 |
|
Integra NeuroSciences, Gravity Compensating Accessory |
10/3/08 |
|
VIBE Technologies, Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Field Generator |
10/1/08 |
|
Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) |
8/28/08 |
|
Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump |
8/4/08 |
|
Medtronic INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit |
6/26/08 |
|
Nebion, LLC HLX-8 Magnetic Resonance Device |
6/25/08 |
|
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System |
6/6/08 |
|
Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) |
3/17/08 |
|
Class II Recall: Chattem, Inc. Icy Hot Heat Therapy Products |
2/12/08 |
|
Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps |
1/16/08 |
|
Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters |
1/14/08 |
|
AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) |
12/20/07 |
|
Cardinal Health Alaris® Infusion Pump Module (formerly Medley™ Pump Module), Model 8100 |
10/29/07 |
|
Welch Allyn AED 10™ Automatic External Defibrillators |
10/26/07 |
|
Thoratec Corporation Implantable Ventricular Assist Devices (IVAD) |
10/19/07 |
|
Medtronic Inc. Sprint Fidelis® Defibrillator Leads |
10/15/07 |
|
Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank |
9/8/07 |
|
MRL/Welch Allyn AED 20™ Automatic External Defibrillators |
8/24/07 |
|
Baxter Upgraded Colleague CX Single Channel Volumetric Infusion Pumps |
8/15/07 |
|
Medtronic Inc. SynchroMed EL Implantable, Infusion Pump |
8/3/07 |
|
Baxa Corporation Exacta-Mix™ 2400 Operating Software Version 1.07 Pharmacy Compound System |
6/27/07 |
|
Baxter Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion Pumps (Updated August 8, 2007) |
6/21/07 |
|
Baxter Healthcare Corp. Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps |
6/20/07 |
|
Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver |
6/8/07 |
|
Bayer Ascensia® Contour® Blood Glucose Monitoring System |
6/6/07 |
|
Advanced Medical Optics, Inc. COMPLETE® MoisturePLUS™ Multi-purpose Contact Lens Solution |
5/25/07 |
|
Integra LifeSciences Corporation (also known as Integra NeuroSciences) EnDura™ No-React® Dural Substitute |
5/4/07 |
|
Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products Troponin I Reagent Pack |
4/27/07 |
|
Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades |
4/27/07 |
|
Sunrise Medical Quickie® Power Wheelchairs |
4/23/07 |
|
Thoratec® Paracorporeal Ventricular Assist System (PVAD) |
3/30/07 |
|
Abbott Laboratories Inc. ARCHITECT® STAT Troponin-I Immunoassay |
3/8/07 |
|
Alcon Refractive Horizons, Inc. LADAR6000 (TM) Excimer Laser System |
2/21/07 |
|
LifeLine® Semi-Automatic External Defibrillators (AEDs) and ReviveR® Semi-Automatic External Defibrillators (AEDs) |
2/17/07 |
|
HoMedics® Thera-P® Heating Pads |
2/9/07 |
|
Smith & Nephew, Inc. Radiofrequency Denervation Probes |
1/19/07 |
|
Counterfeit OneTouch® Ultra® Blood Glucose Test Strips |
10/13/06 |
|
Counterfeit OneTouch® Basic®/Profile® Blood Glucose Test Strips |
10/10/06 |
|
Cardinal Health Alaris ® SE Infusion Pumps |
8/10/06 |
|
Medtronic Intrathecal Catheter, Model 8731 and Intrathecal Catheter Distal Revision Kit, Model 8598 |
7/21/06 |
|
Disetronic D-TRONplus Insulin Infusion Pump Power Packs |
7/13/06 |
|
Welch Allyn PIC 50™ Automated External Defibrillators |
6/30/06 |
|
Welch Allyn AED 20™ Automated External Defibrillators |
6/15/06 |
|
Medtronic SynchroMed EL Programmable Infusion Pumps |
6/6/06 |
|
Disetronic/Roche Diagnostics Accu-Chek™ Ultraflex-1 Infusion Set |
3/31/06 |
|
Ortho-Clinical Diagnostics VITROS® Immunodiagnostic Products Signal Reagent |
3/28/06 |
|
Respironics PLV Continuum Ventilator (PLVC I) |
3/20/06 |
|
The First Years® Liquid-Filled Teething Rings |
1/25/06 |
|
Blackstone Medical, Inc. ICON® Modular Spinal Fixation System |
12/23/05 |
|
Bard® Composix® Kugel® Mesh Patch - Expansion |
12/22/05 |
|
Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit |
12/15/05 |
|
Baxter Healthcare Corp. COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps |
12/13/05 |
|
Boston Scientific Flextome® Cutting Balloon Systems |
12/7/05 |
|
Boston Scientific Stainless Steel Greenfield® Vena Cava Filters |
12/2/05 |
|
Vapotherm, Inc. Vapotherm® 2000i and 2000h Respiratory Gas Humidifier |
10/13/05 |
|
Baxter Meridian® Hemodialyis (HD) Instrument |
9/28/05 |
|
Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps |
9/19/05 |
|
bioMérieux, Inc. VeriCal® Calibrator Sets |
8/19/05 |
|
Gambro Renal Products Prisma® Continuous Renal Replacement System |
8/16/05 |
|
Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps |
7/19/05 |
|
Guidant Corp. Pacemakers |
7/18/05 |
|
CONTAK RENEWAL and CONTAK RENEWAL 2 CRT-Ds |
6/29/05 |
|
Ventak PRIZM 2 DR ICDs |
6/29/05 |
|
Boston Scientific Hemashield® VANTAGE™ Vascular Grafts |
6/27/05 |
|
Vail Products, Inc. Enclosed Bed Systems |
6/24/05 |
|
Abbott Blood Glucose Meters |
6/7/05 |
|
Laerdal Medical Corp. CM 100 Heartstart® Automatic External Defibrillator Adapter Cables |
4/29/05 |
|
Welch Allyn Co., AED 20®, Automatic External Defibrillator |
4/28/05 |
|
LifeScan, Inc. Blood Glucose Meters |
4/11/05 |
|
BioMerieux Simplastin HTF Tissue Reagent |
3/7/05 |
|
HeartSine Technologies, Inc. Automatic External Defibrillators |
2/14/05 |
|
MicroScan® Rapid Pos Inoculum Broth |
2/7/05 |
|
Certain Medtronic LIFEPAK 500 Automated External Defibrillators |
2/5/05 |
|
IV Flush Heparin and Saline IV Catheter Flushes |
1/26/05 |
|
Becton Dickinson ProbeTec ET Urine Processing Kit |
1/10/05 |
|
BioMed Unomedical Airway Adapter |
12/2/04 |
|
Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor |
11/19/04 |
|
Access CardioSystems Automated External Defibrillators |
11/3/04 |
|
Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills |
10/27/04 |
|
Pulmonetic Systems LTV Series of Ventilators |
9/8/04 |
|
Medtronic 8870 Software Application Card Version AAA 02 |
8/24/04 |
|
Nellcor CapnoProbe Sublingual Sensor |
8/24/04 |
|
Medibo Minerva Patient Lifts |
8/4/04 |
|
Boston Scientific Express2TM (bare metal) Coronary Stent |
7/16/04 |
|
Shiley Tracheosoft Tracheostomy Tube and Disposable Inner Cannula |
7/8/04 |
|
Boston Scientific Taxus™ Express2TM (paclitaxel-eluting) Coronary Stent |
7/1/04 |
|
Arjo Alenti Lift Hygiene Chair |
6/8/04 |
|
Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack |
6/7/04 |
|
Carl Zeiss Meditec Ophthalmic System |
6/3/04 |
|
Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers |
5/24/04 |
|
Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation |
5/5/04 |
|
Roche Diagnostics Tecan Clinical Workstation |
5/5/04 |
|
PRECISE® RX Nitinol Stent Transhepatic Biliary System |
5/4/04 |
|
Tecan Clinical Workstation with RoboNet Software |
5/3/04 |
|
Arjo MINSTREL Patient Lifts |
4/30/04 |
|
VITEK GPS-107 Cards (Additional Lot) |
4/20/04 |
|
Micro Jewel II and GEM DR ICDs (implantable cardioverter-defibrillators) |
4/4/04 |
|
Roche Diagnostics Tecan Clinical Workstation |
3/5/04 |
|
MiniMed Paradigm Quick-set Plus Insulin Administration Set |
3/2/04 |
|
VITEK GPS-107 Cards |
1/28/04 |
|
Faaborg Patient Lifts |
1/21/04 |
|
ComfortGel Nasal Masks |
9/29/03 |
|
CoaguChek PT Test Strips |
9/12/03 |
|
Laboratory Information System Software Device, version 5.3 |
8/12/03 |
|
VIDAS Chlamydia Assay |
8/6/03 |
|
ProbeTec ™ ET Instrument |
7/21/03 |
|
Tosoh Bioscience AIA-600 II Analyzers |
4/2/03 |
|
Portex Resuscitator |
11/15/02 |
|
Baxter Intravenous Filter Sets |
10/17/02 |
|
CAPTIA Syphilis G Elisa Test Kit |
7/22/02 |
|
Disetronic D-TRON Insulin Infusion Pump |
6/17/02 |
|
Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800 |
6/3/02 |
|
Bassinets with drop leaf work surface, models 248 and 1251 |
3/20/02 |
|
Class 1 Medical Device Recall: Infant Bassinet |
3/20/02 |
|
Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800 |
3/12/02 |
|
Bard RapidFire Multiple Band Ligator (Item No. 000608) |
1/31/02 |
|
Solar 9500 Physiological ECG Monitor |
7/20/01 |
|
ESPRIT Ventilator |
6/8/01 |
|
Adcon-L and Adcon-T/N sterile |
1/19/01 |
|
Puritan-Bennett Ventilator, Model 840 containing Revision E-level software |
12/22/00 |
|
Gelfoam Sterile Power and Sponge |
11/17/00 |
|