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 News | News By Subject | News by Disease News By Date | Search News
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Medical Dev. & Diag. - Recalls and Warnings
Endo Health Solutions Inc. (ENDP) Unit Receives FDA Warning Letter Tied To Form 483 Notice 4/17/2014  More...
New Warnings For Medtronic, Inc. (MDT)'s Paradigm Insulin Pumps 4/15/2014  More...
Covidien plc (COV) Recalls Its Pipeline™, Alligator™ Brain Aneurysm Devices 4/11/2014  More...
Draeger Recalls Ventilators Over Battery Issues 4/4/2014  More...
Thoratec Corporation (THOR) LVAD Recall Gets Class I Status 4/2/2014  More...
GE Healthcare Recalls Hundreds Of Baby "Warmers" In China Over Safety Fears 4/1/2014  More...
FDA Slaps DexCom With Warning Over Deficiencies In Medical Device Reports 3/25/2014  More...
Playtex Recalls Breast Pump Adapters Over Electrical Shock Risk 3/21/2014  More...
Abbott Diagnostics Recalls Blood Glucose Meters Over False Readings 3/18/2014  More...
McKesson Technologies Inc. Anesthesia Care Recalled Over Patient Data Issues 3/18/2014  More...
Merit Medical Systems, Inc. (MMSI) Gets FDA's Highest-Risk Label Over Hospira, Inc. Injections 3/14/2014  More...
Hospira, Inc. Racks Up Another Warning Letter 3/13/2014  More...
Fitbit Recalls Force Activity-Tracking Wristband Due To Risk Of Skin Irritation 3/13/2014  More...
Philips Healthcare Ventilator Recalled Over Power Management Flaw 3/10/2014  More...
Baxter International, Inc. (BAX) Initiates U.S. Voluntary Recall Of One Lot Of Peritoneal Dialysis Solution Due To Container-Closure Non-Integrity 3/7/2014  More...
GE Healthcare Recalls Infant Resuscitators over Serious Assembly Error 3/6/2014  More...
Four Deaths Linked To Thoratec Corporation (THOR)'s Heartmate II® LVAS Pocket System Controller 3/5/2014  More...
Medline Industries, Inc. Guidewires Recalled Over Serious Coating Problems 3/3/2014  More...
St. Jude Medical (STJ) Warns About Surgery With Older Pacemakers 2/26/2014  More...
New Breast Implant Recall In The EU Prompts Need For VeriTeQ Corporation (VTEQ)’s Device Traceability Technology 2/24/2014  More...
FDA Warns Baxter International, Inc. (BAX) On Homechoice Dialysis System, Infusion Pump 2/21/2014  More...
Philips Respironics Initiates Recall Of Trilogy Ventilator 2/20/2014  More...
Amgen (AMGN) Hit With FDA Warning Over Drug-Device Combos 2/17/2014  More...
Baxter Healthcare Corporation (BAX) Facility Gets Another FDA Warning Letter 2/17/2014  More...
Teleflex Medical Voluntary Recalls ISIS™ HVT™ Tracheal Tubes Cuffed With Subglottic Secretion Suction Port 2/13/2014  More...
HeartSine Technologies, Inc Warned By FDA For Medtech Reporting, Tracking Violations 2/13/2014  More...
Johnson & Johnson (JNJ)'s Codman Neuro Recall Elevated To High Risk Class I 1/23/2014  More...
Potentially Fatal Complication Found In Heart Valve Manufactured By Sorin Group S.p.A. (SRN) 1/22/2014  More...
Tandem Diabetes Care Widens Recall Of Insulin Pump Cartridges 1/21/2014  More...
FDA Dings Philips On InnerCool RTx Component Recall 1/16/2014  More...
Software Glitch In Covidien (COV) Ventilator More Serious Than Thought, Could Be Deadly: FDA 1/15/2014  More...
Tandem Diabetes Care Recalls Some T:slim Insulin Pump Cartridges 1/13/2014  More...
FDA Slaps Covidien plc (COV) Ventilator With A Class I Recall Tag 1/10/2014  More...
OraSure Technologies, Inc. (OSUR)'s DNA Genotek Slapped WIth A Warning Letter From The FDA 1/7/2014  More...
Nipro Diagnostics, Inc. Initiates Voluntary Recall Of Certain TRUEbalance And TRUEtrack Blood Glucose Meters 1/3/2014  More...
GE Healthcare's Vital Signs Devices Takes Action After Discovering Potential Health Risk From CO2 Multi Absorber 12/31/2013  More...
FDA: Intuitive Surgical, Inc. (ISRG)'s da Vinci Surgical Robots Slapped With Class II Recall 12/19/2013  More...
FDA Warns On Atossa Genetics, Inc. (ATOS)'s Aspirate Test For Breast Cancer 12/16/2013  More...
FDA Warns Of Problems With Philips Healthcare's Heart Devices 12/4/2013  More...
Intuitive Surgical, Inc. (ISRG)'s Robots May Stall In Surgery 12/4/2013  More...
Abbott Diabetes Care (ABT) Recalls Blood Glucose Test Strips 12/3/2013  More...
Hospira, Inc. (HSP) GemStar Pump System Gets Deadly Recall From The FDA 11/26/2013  More...
FDA Warns Of Heart Risks With Astellas Pharma Inc. (ALPMY) Stress Test Chemicals 11/21/2013  More...
Recalled Medtronic, Inc. (MDT) Guidewires Potentially Fatal: FDA 11/18/2013  More...
Maker Of Recalled Breast Implants, Poly Implant Prothese, On The Hook For Damages 11/15/2013  More...
Atossa Genetics, Inc. (ATOS) Slapped With Class 1 Recall, Marketed Product Without Approval Or Clearance 11/13/2013  More...
FDA Hits Baylis Medical's TorFlex Transseptal Guiding Sheath Kit With Class I Recall 11/7/2013  More...
Edwards Lifesciences Corporation (EW)'s EMBOL-X Glide Protection System Slapped With Class 1 Recall Over Deformed Tips 11/5/2013  More...
Nephros Inc. (NEP) Plummets 68% on Filter Recall 10/31/2013  More...
PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve 10/31/2013  More...
King Systems Slapped With FDA Warning Letter 10/30/2013  More...
GE Healthcare's Ventilator/Anesthesia Machines Slapped With Class 1 Recall by FDA 10/28/2013  More...
Novo Nordisk A/S (NVO) Recalls Batches of FelxPen, Penfill Insulin in Europe 10/25/2013  More...
U.K. Healthcare Regulators Warn of "Buckling" Becton Dickinson AG Catheters 10/24/2013  More...
Medtronic, Inc. (MDT) Recalls Dilation Catheters Over Labeling Issue 10/23/2013  More...
H&H Medical's Emergency Crichothyrotomy Kit Whacked With Class 1 Recall: FDA 10/23/2013  More...
CareFusion 211 Slapped With FDA Warning Third Time This Year 10/22/2013  More...
FDA Slaps Class I Recall on C.R. Bard's LifeStent Solo Vascular Stent 10/21/2013  More...
FDA Warns of Small Risk With St. Jude Medical (STJ)'s Amplatzer Heart Device 10/18/2013  More...
HeartSine Technologies, Inc Recalls Some PDU400 Defibrillators 10/17/2013  More...
The Real Erin Brockovich Takes on Bayer AG (BAYN.DE)'s Birth Control 10/17/2013  More...
Voluntary Field Corrective Action Issued for GE Healthcare’s Engström Ventilator and Aespire View, Aisys, and Avance Anesthesia Machines 10/16/2013  More...
Globus Medical, Inc. (GMED) Reveals FDA Warning Letter Over MicroFuse Putty 10/15/2013  More...
Draeger Issues an Update on Its Voluntary Recall of Fabius Anesthesia Machines 10/8/2013  More...
CareFusion Corporation Provides Update on Voluntary Recall of AVEA® Ventilator 10/1/2013  More...
Integra LifeSciences Holdings Corporation (IART) Resolves Violations at New Jersey Manufacturing Facility 9/26/2013  More...
Baxter International, Inc. (BAX) Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps 9/20/2013  More...
More Fall Concerns for Large Imaging Systems as Philips Healthcare Issues Warning 9/20/2013  More...
GE Healthcare Issues Another Imaging System Fall Warning After Discovering Missing Screws 9/19/2013  More...
HeartSine Technologies, Inc Issues Global Correction of Samaritan® 300/300P PAD 9/17/2013  More...
Siemens Healthcare Diagnostics Recalls MicroScan Synergies Plus® and RapID/S plus Gram Negative Panels 9/17/2013  More...
RTI Surgical (RTIX) Spikes After Dodging FDA Warning 9/16/2013  More...
Rented Medtronic, Inc. (MDT) Equipment May Have Exposed 13 Patients With Fatal Brain Disease 9/6/2013  More...
Defect Leads Siemens (SI) to Recall 78,000 MicroScan Panels 9/5/2013  More...
Stryker Corporation  (SYK) Recalls Spine Surgery Device, Tagged With FDA's "Deadly" Label 8/29/2013  More...
FDA Hits Fresenius AG With 3rd Warning Letter This Year 8/27/2013  More...
FDA Warns on Oxygen Chamber Scams 8/26/2013  More...
FDA Should Warn Against Prolonged Use of Plavix for Stent Patients, Says U.S. Consumer Group 8/22/2013  More...
Covidien plc (COV) Recalls Some Prefill Flush Syringes 8/20/2013  More...
Recall: FDA Sounds the Alarm on Hospira, Inc. (HSP) Blood Kits After 1 Patient Dies 8/16/2013  More...
CircuLite Warns on Synergy Heart Pumps After Receiving Cannula Fracture Reports 8/16/2013  More...
Menarini Group's Glucose Testing Strips Recalled Over False Reading Worry 8/16/2013  More...
LMT Surgical Recalls Shoulder Implants Amid 3% Fracture Rate 8/15/2013  More...
Aimedics Recalls All HypoMon Sleep Glucose-Monitoring Devices 8/14/2013  More...
FDA Issues Class I Recall on Infusion Technology Made by IRadimed Corporation 8/14/2013  More...
Class 1 Recall Issued to Cordis Corporation (JNJ)'s Optease Retrievable Inferior Vena Cava (IVC) Filter 8/8/2013  More...
Class 1 Recall Issued for CareFusion Corporation's - Alaris PC Unit (Model 8015) With Version 9.12 Keyboard Processor 8/8/2013  More...
DePuy Orthopaedics, Inc. (JNJ)'s Limb Preservation System Slapped With Class 1 Recall 8/2/2013  More...
Nova Biomedical Recalls Glucose Test Strips 7/31/2013  More...
Hospital Death Forces Recall of GE Healthcare's Nuclear Medicine Machines 7/30/2013  More...
Johnson & Johnson (JNJ) Subsidiary Gets Class I Recall for Implantable Infusion Pumps 7/26/2013  More...
LeMaitre Vascular, Inc. Graft Recall Gets FDA's Highest Warning 7/25/2013  More...
FDA Slaps Ohio-Based Bryan Medical With Its Highest-Risk Recall 7/25/2013  More...
Stryker Corporation  (SYK) Pulls Spinal Devices Off the Shelves Following Failure Reports 7/24/2013  More...
DePuy, Inc. Warns Surgeons on Fracture Risk in Limb Preservation System 7/24/2013  More...
Philips Healthcare HeartStart MRx Defibrillator Recall Affects 65K Devices Worldwide 7/18/2013  More...
Medtronic, Inc. (MDT) Recalls Implantable Pacemakers Over Manufacturing Concerns 7/16/2013  More...
FDA Recalls Medtronic, Inc. (MDT) Insulin Pumps Recall Over Insulin Worries 7/15/2013  More...
Intuitive Surgical, Inc. (ISRG) May Not Have Tested Devices Properly 7/12/2013  More...
FDA Puts Highest-Risk Label on Verathon Inc.'s Reusable Laryngoscope Recall 7/12/2013  More...
Integra LifeSciences Corporation (IART) Recall Affects Medtronic, Inc. (MDT)'s Infuse Kits 7/3/2013  More...
Medtronic, Inc. (MDT)'s SynchroMed Linked to 14 Deaths 6/28/2013  More...
FDA: Intuitive Surgical, Inc. (ISRG) Failed to Report Warning 6/26/2013  More...
FDA Bars Medtronic, Inc. (MDT) Catheter Imports Amid "Serious" Miscues 6/26/2013  More...
Medtronic, Inc. (MDT) Recalls Surgical Breathing Tube 6/24/2013  More...
Respironics, Inc. (RESP) Ventilators Recalled for Software Malfunctions 6/21/2013  More...
Fresenius Medical Care Receives FDA Warning Letter 6/19/2013  More...
St. Jude Medical (STJ)'s Durata Defibrillator "Immune" to Riata Flaws? 6/19/2013  More...
Endologix Inc. AFX Introducer System: Class 1 Recall - Reports of Dilator Breaking During Procedures 6/18/2013  More...
FDA Urges Protection of Medical Devices From Cyber Threats 6/14/2013  More...
Cook Medical: Trouble Ahead Following Zilver PTX Stent Recall 6/12/2013  More...
Labeling Issues Plague Boston Scientific Corporation (BSX)'s Balloon Dilators 6/11/2013  More...
Intuitive Surgical, Inc. (ISRG) Ships New Surgical Scissors Following Crack Warning 6/6/2013  More...
Nephron Pharmaceuticals' EZ Breathe Atomizer Tagged With Class 1 Recall 6/5/2013  More...
FDA Warns CooperSurgical, Inc. About Texas Manufacturing Plant 5/31/2013  More...
FDA Warns Edwards Lifesciences (EW) on Quality 5/30/2013  More...
Boston Scientific Corporation (BSX) Wants Major Changes to Recall/Enhancement Draft Guidance 5/30/2013  More...
U.K. Regulators Warn on Unomedical's Endotracheal Tubes 5/29/2013  More...
Chinese Regulators Warn of Software Glitch in Philips Healthcare's Pinnacle3 Radiation Therapy Software 5/29/2013  More...
FDA Gives Cook Medical's Zilver PTX Drug-Eluting Peripheral Stent a Serious Warning 5/28/2013  More...
Symbios Medical Products Recalls GoPump and GOBlock Kits Following Patient Complaints 5/23/2013  More...
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...





 

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