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Medical Dev. & Diag. - Recalls and Warnings
FDA Pins Abbott Diabetes Care (ABT)'s FreeStyle InsuLinx Blood Glucose Meters With Class 1 5/20/2013  More...
Roche (RHHBY) Recalls CoaguChek Monitors 5/20/2013  More...
Johnson & Johnson (JNJ) to Discontinue Metal-on-Metal Hip Products 5/17/2013  More...
FDA Warns Hospira, Inc. (HSP) -- Again 5/16/2013  More...
Maquet Cardiovascular LLC's Class I Ventilator Battery Recall Affects 90k Units 5/16/2013  More...
Australia Recalls a Johnson & Johnson (JNJ) Device 5/14/2013  More...
Intuitive Surgical, Inc. (ISRG) Warns on Da Vinci Scissor Crack Risk 5/13/2013  More...
FDA Warns Covidien (COV)'s Stolen Stapler Reloads Up for Sale Before Sterilization 5/8/2013  More...
Cardinal Health, Inc. (CAH) Recalls Pre-Assembled Filter and Anesthesia Circuit in Packs 5/7/2013  More...
Medtronic, Inc. (MDT) Warns on Wire Damage Risk With Deep-Brain Stimulation Implants 5/3/2013  More...
Cook Medical Initiates Global Recall of Its Zilver® PTX®Drug Eluting Stent 4/25/2013  More...
GE Healthcare Warns on Certain Giraffe Infant Care Systems 4/24/2013  More...
Covidien plc (COV) Recalls Power Pac Batteries for Newport™ HT70 and HT70 Plus Ventilators 4/19/2013  More...
FDA Cites Baxter Healthcare Corporation (BAX) for Selling Pump Without PMA 4/17/2013  More...
Abbott Laboratories (ABT) Recalls FreeStyle InsuLinx Glucose Meters 4/15/2013  More...
Integra LifeSciences Corporation (IART) Recalls Some Collagen Items 4/12/2013  More...
HeartWare (HTWR) Device Malfunction Led to Death, FDA Reports 4/11/2013  More...
Recall: Hoya Surgical Optics, Inc. Pulls Intraocular Lenses 4/11/2013  More...
CareFusion Corporation Hit by Another Warning for Its Alaris Infusion Pump 4/9/2013  More...
A Real False Alarm: Johnson & Johnson (JNJ) Recalls Another Product 4/8/2013  More...
Spacelabs Healthcare Pulls Anesthesia Workstations Over Excess CO2 Risk 3/28/2013  More...
Stereotaxis, Inc. (STXS) Receives Delisting Warning From Nasdaq 3/26/2013  More...
Asia Recalls Merck Sharp & Dohme (MRK)'s Contraceptive Devices 3/26/2013  More...
LifeScan, Inc.'s OneTouch Verio IQ Blood-Glucose Meters Recalled 3/25/2013  More...
NuVasive, Inc. (NUVA) Ticketed With FDA Warning Letter 3/20/2013  More...
Symbios Medical Products' PumpKit Slapped With Recall 3/19/2013  More...
Vascular Solutions (VASC) Issues Recall on Guardian® II and Guardian II NC Hemostasis Valves Due to Risk of Air Embolism 3/19/2013  More...
Fresenius Medical Care AG & Co. KGaA (FMS) Reveals FDA Warning Letter 3/15/2013  More...
Johnson & Johnson (JNJ) Exec Says Hip Implant Was Recalled for Clinical Reasons 3/14/2013  More...
FDA Warns Stryker on Quality Issues, Marketing Practices 3/12/2013  More...
Honey, Pass the… Uh-Oh, Johnson & Johnson (JNJ) Recalls K-Y Jelly 3/8/2013  More...
FDA Issues Warning Letter to Medtronic, Inc. (MDT) CoreValve Investigator 2/28/2013  More...
FDA Slaps Lumenis Ltd. (LUME) Recall With Class I Status 2/26/2013  More...
Johnson & Johnson (JNJ) Recalls Knee Replacement Device 2/25/2013  More...
FDA Sends Warning Letter to Atossa Genetics, Inc. (ATOS) 2/25/2013  More...
FDA Cites Alcon, Inc. (ACL) for Improperly Marketing Laser 2/22/2013  More...
Johnson & Johnson (JNJ)'s Toxicologist Says Metal From Recalled Hip Harmless 2/22/2013  More...
DePuy Orthopaedics, Inc. (JNJ) Knew of Problems Well Before Recall 2/19/2013  More...
FDA Sends Warning Letter to Rigid FX Orthopedics for the Clearview Wrist Fixation System 2/15/2013  More...
FDA Lays Down 2 Warning Letters for Bacterin International, Inc. 2/15/2013  More...
Johnson & Johnson (JNJ) Warns of Safety Risk for 7,500 Non-U.S. Hip Implants 2/15/2013  More...
Hospira, Inc. (HSP) Gets FDA Notice Over Medical Device Problems 2/14/2013  More...
FDA Slaps Highest Risk Label on St. Jude Medical (STJ)'s Amplatzer TorqVue FX Recall 2/13/2013  More...
HeartWare (HTWR) Warns of Heart Device Defect 2/11/2013  More...
Hamilton Medical, Inc. Recalls Ventilators Over Software Glitch 2/7/2013  More...
GE Healthcare Announces Class I Recall of Infant Resuscitation Kits 2/4/2013  More...
Vycor Medical Inc. Recalls Brain Access System Over Potential Contamination 1/31/2013  More...
ICU Medical, Inc. (ICUI) to Discontinue CLC2000 Devices 1/28/2013  More...
FDA Smacks Bausch & Lomb With a Recall 1/24/2013  More...
Analysts Say St. Jude Medical (STJ) May Face New Recall 1/17/2013  More...
Recall of Selected Lots of 2 Brands of ACUVUE Contact Lenses 1/16/2013  More...
FDA Releases St. Jude Medical (STJ) Warning Letter 1/16/2013  More...
Use of New Boston Scientific Corporation (BSX) Device Should be Limited: Doctor 1/3/2013  More...
Fire Risk Leads Praxair, Inc. (PX) to Recall Grab 'n Go Oxygen Tanks 1/3/2013  More...
FDA Recalls 2 Ventilator Models From Ventlab 1/2/2013  More...
FDA Sends Warning Letter to Mindray Medical Over Manufacturing Problems 1/2/2013  More...
GE Healthcare Recalls Resuscitator Components 1/1/2013  More...
Fake Allergan Inc. (AGN) Botox Warning by FDA to 350 Medical Practices 12/27/2012  More...
Bunnell Incorporated Ventilator Products Recalled 12/27/2012  More...
Medtronic, Inc. (MDT) Recall Gets Class I Status From FDA 12/27/2012  More...
FDA Warns on Improper Lasik Ads 12/20/2012  More...
Zimmer Spine, Inc. Issues Worldwide Recall of all 315 Units of the PEEK Ardis® Inserter 12/20/2012  More...
Recalls: Haemonetics Corporation (HAE) Warns on Potential Leaks 12/18/2012  More...
Ethicon, Inc. (JNJ) Class I Recall - Potential for Packaging Breach 12/14/2012  More...
Natus Medical Incorporated (BABY) Cooling Cap Hit With FDA Class I Recall 12/13/2012  More...
Radiation Danger Alert for Handheld Dental X-Ray Machines From Zhengzhou Tianjie Electronic Equipment Co. 12/4/2012  More...
Verathon Inc. Recalls GlideScope GVL Video Laryngoscopes 11/30/2012  More...
Bracco Diagnostics Inc. Recalls Isovue PFS Injector Syringes 11/28/2012  More...
Report Raises Concerns Over St. Jude Medical (STJ) Heart Device 11/21/2012  More...
Another Warning for CareFusion Corporation's Alaris Infusion Pumps 11/16/2012  More...
Mindray Medical has Initiated a Voluntary Recall of A3/A5 Anesthesia Delivery System 11/14/2012  More...
Integra LifeSciences Corporation (IART)'s UK Facility Gets FDA Warning Letter 11/13/2012  More...
Baxter Healthcare Corporation (BAX) Issues Class 1 Recall on Buretrol Solution Sets 11/9/2012  More...
Feds Closed Probe Into Edwards Lifesciences Corporation (EW)'s Recalled Vigilance Heart Monitor 11/8/2012  More...
AMS Recalls Its AdVance Male Sling System 11/6/2012  More...
FDA Warns Light Therapy Maker, Avalon Effect Inc., for Fungal Meningitis Treatment Claims 11/6/2012  More...
Johnson & Johnson (JNJ) Recalls Surgical Stapler Devices Over Serious Safety Issue 10/29/2012  More...
FDA Smacks Johnson & Johnson (JNJ) With Class I Recall Over Symbiq Infusion System 10/29/2012  More...
St. Jude Medical (STJ) Receives FDA Warning Letter About One of Its Facilities 10/25/2012  More...
FDA Labels Accutron Recall Class I Over Nitrous Oxide Leak That May Harm Patients 10/17/2012  More...
Accutron, Inc. Issues Nationwide Voluntary Recall of Flowmeters 10/9/2012  More...
FDA Warns Against Use of Stryker Corporation  (SYK) Surgical Suction Systems Due to Report of a Death 10/8/2012  More...
MS Patients Seek Therapy Despite FDA Warning 10/8/2012  More...
FDA Warns Zimmer (ZMH) Over Manufacturing of Hip Devices 10/2/2012  More...
Stryker Corporation  (SYK) Recalls Neptune Devices After Death Reported 9/26/2012  More...
Stryker Orthopaedics Recalls Rejuvenate Modular Hip Systems 9/26/2012  More...
Philips Healthcare's Respironics, Inc. (RESP) Issues Another Ventilator Recall 9/4/2012  More...
I-Flow Corporation (IFLO) Recalls ON-Q Pump With ONDEMAND Bolus Button 9/4/2012  More...
Baxter Healthcare Corporation (BAX) Recalls Automix Nutrition Compounder Systems 8/30/2012  More...
FDA Warns Hospira, Inc. (HSP) Over Costa Rica Infusion Device Plant 8/29/2012  More...
FDA Asks Johnson & Johnson (JNJ)'s DePuy Orthopaedics, Inc. (JNJ) to Recall Unused Custom Implants 8/27/2012  More...
FDA Recalls Another CareFusion Corporation Infusion Pump 8/23/2012  More...
Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa 8/22/2012  More...
Medtronic, Inc. (MDT)’s Drug Pump Failure Prompts FDA Meeting Request 8/22/2012  More...
Johnson & Johnson (JNJ) Unit Recalls Bone Putty 8/22/2012  More...
Covidien plc (COV) Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits That Contain DGPHP RFA High-Power Single Use Grounding Pads 8/20/2012  More...
Johnson & Johnson (JNJ) Recall: Ethicon Endo-Surgery, Inc. Pulls Surgical Staplers 8/13/2012  More...
FDA Issues Warning for Fake Medical Equipment 8/7/2012  More...
B. Braun Medical Ltd. Infusion System Part of Class I Recall 8/3/2012  More...
DUKAL Corporation Antiseptic Wipes Made in China Pulled in U.S. 8/2/2012  More...
FDA Classifies Recall of a Component of CareFusion Corporation's Alaris Infusion Pump as Class I 8/2/2012  More...
St. Jude Medical (STJ) Recalls Eon, Eon Mini Pain Management Implants on Battery, Charging Issues 8/1/2012  More...
Arrow International, Inc. (ARRO) Multi-Lumen Venous Catheterization Set With Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient 7/31/2012  More...
Johnson & Johnson (JNJ) Recalls Some Duragesic Pain Patches 7/20/2012  More...
Respironics, Inc. (RESP) Issues Voluntary Recall of a Limited Number of Trilogy Ventilators 7/18/2012  More...
CareFusion Corporation Provides Update on Voluntary Recall of EnVe® Ventilator 7/18/2012  More...
Alere Inc. (ALR) Recalls 897,000 Heart Attack, Drug Test Kits 7/12/2012  More...
GE Healthcare Recalls Some Ventilators on Safety Issue 7/12/2012  More...
Stryker Recalls Certain Hip Implant Products 7/9/2012  More...
China Regulators Warn on Pace Medical Corporation's Micro-Pace Pacemakers 7/9/2012  More...
MAQUET Initiates Class I Recall of the FLOW-i Anesthesia System 7/6/2012  More...
CareFusion Corporation Recalls Infant Breathing Product 7/3/2012  More...
U.K.'s Medicines & Healthcare Products Regulatory Agency Warns on Reusable Probes Following Patient Death 6/29/2012  More...
FDA Warns Covidien plc (COV) Over Surgical-staple Deaths 6/28/2012  More...
FDA Probing Safety of Metal-on-Metal Hip Implants 6/27/2012  More...
St. Jude Medical (STJ)'s Riata Leads Recalled Because of the Potential Risk of Serious Injury or Patient Death if the Device Malfunctions 6/22/2012  More...
FDA Issues a Class 1 Recall on Nidek Medical Products, Inc.'s Oxygen Concentrators 6/20/2012  More...
Fresenius Medical Care's Failure to Warn of Product Risk Draws Inquiry 6/15/2012  More...
Ethicon Endo-Surgery, Inc. Warns on Counterfeit Surgical Clips on the U.S. Market 6/14/2012  More...
St. Jude Medical (STJ) Shares Drop on Report of Heart Lead Problem 6/13/2012  More...
Johnson & Johnson (JNJ)'s Cordis Corporation (JNJ) Unit Recalls Catheters 6/13/2012  More...
Siemens Healthcare Diagnostics Gets Warning Letter Over Blood Sample Testing Device 6/7/2012  More...
Johnson & Johnson (JNJ) to Halt Sales of Vaginal Mesh Implants 6/5/2012  More...
Smith & Nephew Inc. (SNN) Withdraws Hip Device Component 6/4/2012  More...
FDA Issues Class I Recall on Other-Sonic Ultrasound Gel 6/1/2012  More...
FDA Warns Johnson & Johnson (JNJ) Over Vaginal Products 5/31/2012  More...
BC Cancer Agency Recalls Cervical Cancer Treatment Device 5/29/2012  More...
FDA Panel Wants a Closer Look at St. Jude Medical (STJ) Heart Implant 5/29/2012  More...
Moog Medical Devices Group Recalls IV Sets for Reverse Fluid Flow 5/25/2012  More...
Alere Inc. (ALR) Recalls 803,000 Tests for Heart Attacks 5/24/2012  More...
Covidien plc (COV) Recalls Roticulator Staplers 5/21/2012  More...
Medical Device Alert on TaiDoc's Blood Glucose Monitoring System 5/18/2012  More...
Department of Homeland Security Issues Warning on Medical Device Threats 5/17/2012  More...
Vascular Expert Supports FDA Warning About Experimental Therapy for MS Patients 5/14/2012  More...
SEC Probes Baxter International, Inc. (BAX) on Infusion Pump Recalls 5/8/2012  More...
Roche Diagnostics Corporation (ROG.VX) Recalls Two Troponin I Assays 4/25/2012  More...
FDA Cites Orthopedic Medical Device Company Extremity Medical Over Violations 4/25/2012  More...
FDA Issues Warning Over Fentanyl Patches; Makers Include Mylan Inc. (MYL) and Watson Pharmaceuticals, Inc. (WPI) 4/23/2012  More...
US Marshals Seize Pharmaceutical Innovations' Contaminated Ultrasound Gel That Allegedly Sickened 16 Patients 4/20/2012  More...
More Recalls/Warnings on Johnson & Johnson (JNJ)'s Metal-on-metal Hip Implants in Australia, U.K, New Zealand 4/16/2012  More...
Thoratec Corporation (THOR)'s Heartmate II Pump Recalled 4/6/2012  More...
Oxygen Therapy Device for Wound Healing from Ogenix Corporation Gets FDA Warning Letter 4/5/2012  More...
St. Jude Medical (STJ) Yanks Brio Deep Brain Stimulator After 11 Malfunctions 3/30/2012  More...
Two Medical Device Companies, Orthopedic Alliance and Spinal Solutions, Receive FDA Warnings 3/29/2012  More...
Lucero Medical's Spinal Fusion Device Draws FDA Warning Letter 3/29/2012  More...
Smiths Medical, Inc. Issues a Market Withdrawal for CoZmonitor Blood Glucose Monitoring Systems 3/29/2012  More...
St. Jude Medical (STJ)'s Frayed Heart Wires May Have More Risky Defects 3/26/2012  More...
Medtronic, Inc. (MDT)'s EnTrust Gets U.K. Safety Alert for Battery Life 3/19/2012  More...
Acclarent, Inc. Recalls Inspira AIR Balloon Dilation System 3/14/2012  More...
Life Recovery Systems Receives Warning Letter Over Surgery Prep Device 3/14/2012  More...
DH Recalls Eumed Biotechnology Co. Ltd.'s EUKARE Blood Glucose Test Strip 3/5/2012  More...
Johnson & Johnson (JNJ) Sold FDA Rejected Hip Implants Abroad 2/15/2012  More...
St. Jude Medical (STJ) Device Exposes Safety Monitoring Failures, Doctor Says 2/15/2012  More...
Hitachi Medical Corporation's Analyzer Recalled Due to False Results 2/10/2012  More...
Merit Medical Systems, Inc. (MMSI) Receives FDA Warning Letter Regarding Merit Laureate(R) Hydrophilic Guidewire 2/8/2012  More...
Medicines and Healthcare Products Regulatory Agency Issues Alert for Coloplast's Catheter Valve 2/2/2012  More...
Health Warning Over DePuy Orthopaedics, Inc. (JNJ)'s Hip Implants 1/31/2012  More...
Covidien (COV) Unveils Expanded Recall of Brain Sensors 1/20/2012  More...
FDA Warns Johnson & Johnson (JNJ)'s DePuy Orthopaedics, Inc. (JNJ) Unit on Custom Devices 1/19/2012  More...
FDA Warns Thoratec Corporation (THOR) on Late Filings 1/19/2012  More...
Covidien (COV) Says Device Linked to Three Deaths in Thoracic Surgery 1/17/2012  More...
Respironics, Inc. (RESP) Completes Voluntary Recall Notification of a Limited Number of Trilogy 100 Ventilators 1/16/2012  More...
Ikaria Inc. Recalls Drug Delivery System 1/9/2012  More...
Health Equipment Maker Midmark Gets FDA Warning Letter on Sterilizers 1/5/2012  More...
FDA Targets Risks From Reused Medical Devices 12/29/2011  More...
Smiths Medical, Inc. Issues Urgent Device Recall of Certain Bivona® Neonatal, Pediatric, and FlexTend Tracheostomy Tubes 12/28/2011  More...
China's Department of Health Issues Device Alert for Medtronic, Inc. (MDT)'s Cannulae 12/21/2011  More...
French Women "Must Have Faulty Breast Implants Removed" 12/20/2011  More...
Neti Pots Linked to Brain-Eating Amoeba Deaths 12/20/2011  More...
St. Jude Medical (STJ) Hit With Class 1 Recall of Heart Device Leads 12/16/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Device Alert for Hospira, Inc. (HSP)'s Respiration Monitor 12/15/2011  More...
FDA Issues Warning Letters for Misleading Advertising of Allergan Inc. (AGN)'s Lap-Band 12/14/2011  More...
China's Department of Health Issues Device Alert for Smiths Medical, Inc.'s Respiration Monitor 12/14/2011  More...
St. Jude Medical (STJ) Letter Warns Doctors on Defibrillator Lead Failures 12/5/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for GE Healthcare's Gas Outlet 12/2/2011  More...
FDA Investigates Stent "Shrinkage" in Boston Scientific Corporation (BSX)'s Ion, Promus Stents 11/21/2011  More...
Health Canada Issues Device Recall for Sorin Group Canada, Inc.'s Defibrillation Leads 11/17/2011  More...
CooperVision Inc. Announces Expanded Recall of Avaira Line of Contact Lenses 11/16/2011  More...
FDA Issues Recall for Mizuho Orthopedic Systems’ Modular Tables 11/15/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Drive Medical's Bath Lift 11/10/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Microgen Bioproducts' Syphilis Tests 11/9/2011  More...
CareFusion Corporation EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation 11/7/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Drive Medical's Rollator 11/7/2011  More...
FDA Warns Aesculap for Reporting, Procedural Failures 11/4/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Lifecare Hospital Supplies Ltd.'s Jet Adaptors 11/4/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Penlon's Disposable Blades 11/3/2011  More...
CAPA Violations Cited in Warning Letter to Rocket Medical 11/3/2011  More...
China Department of Health Issues Safety Notice for Synthes, Inc. (SYST)' Drill Device 11/2/2011  More...
China Department of Health Issues Safety Notice for Boston Scientific Corporation (BSX) X-Ray Device 11/1/2011  More...
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for NIKKISO Europe GmbH's Haemofiltration Device 10/28/2011  More...
Medicines and Healthcare Products Regulatory Agency Warning Over HIV Home Test Kits 10/28/2011  More...
China Department of Health Issues Recall for Draeger Medical, Inc.'s Device Software 10/25/2011  More...
China Department of Health Issues Recall for Boston Scientific Corporation (BSX)'s Polyp Retrieval Device 10/19/2011  More...
CareFusion Corporation Initiates Class I Recall of EnVe Ventilators 10/19/2011  More...
Encision, Inc. (ECIA) Announces Voluntary Recall of Certain Electrode Product 10/18/2011  More...
China Department of Health Issues Recall for Becton, Dickinson and Company (BDX)'s Syringe Tip Caps 10/17/2011  More...
China Department of Health Issues Recall for Abbott Molecular, Inc.'s Preparation System 10/14/2011  More...
CooperVision Inc. Continues the Voluntary Recall of Avaira(TM) Toric Contact Lenses 10/12/2011  More...
China Department of Health Issues Recall for Vygon's Anti-Reflux Valve 10/12/2011  More...
China Department of Health Issues Recall for Varian Medical Systems (VAR)'s Head Ring Posts 10/10/2011  More...