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Medical Dev. & Diag. - Recalls and Warnings
United Therapeutics Corporation (UTHR) Release: Devices Used with Tyvaso Therapy Being Recalled 7/23/2014
Baxter International, Inc. (BAX) Initiates Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter 7/22/2014
Zimmer (ZMH) Recalls 40,000 NexGen Knee Models 7/18/2014
FDA Warns Zynex Medical Holdings, Inc. Over Chronic Pain Devices 7/9/2014
Vascular Solutions (VASC) Recalls Langston® Dual Lumen Catheters 7/7/2014
FDA Hits ConvaTec's Fecal Management System With A Class 1 Recall 7/7/2014
Medtronic, Inc. (MDT) Issues Class I Recall Of Duet Neuro Drainage And Monitoring Systems 7/3/2014
St. Jude Medical (STJ) Resolves 2013 FDA Warning Letter 7/2/2014
ConvaTec In Hot Water With The FDA After Patients Death, Injuries 6/25/2014
Smith & Nephew Inc. (SNN) Halts U.S. Renasys™ Sales Amid FDA Snafu 6/24/2014
Covidien plc (COV) Recalls Potentially Faulty Hydrofinity Guidewire, Component Is Manufactured By Bay Area Company Nitinol Devices & Components 6/20/2014
Smiths Medical, Inc. Recalls Mislabeled Portex-Brand Intubation Connectors 6/16/2014
Diabetic Supply Of Suncoast, Inc. Issues A Nationwide Voluntary Recall Of BMB-BA006A Advocate Redi-Code+ Blood Glucose Test Strips 6/13/2014
FDA Warns Illinois Device Maker Instrumed On Manufacturing Violations At German Site 6/12/2014
FDA Warns Steris Corporation (STE)-Isomedix On QA, Data Manipulation Issues 6/5/2014
HeartWare (HTWR) Gets Slapped With FDA Warning Letter 6/5/2014
Fresenius Medical Care Recalls Dialysis Concentrate, May Be Contaminated 5/30/2014
FDA Warns On Fisher & Paykel Healthcare's Infant CPAP Systems Following Dozens Of Complaints 5/27/2014
CareFusion Corporation Hit With Another High-Risk Recall Over Alaris Infusion Pumps 5/23/2014
Fresenius Medical Care Recalls 56 Lots Of Naturalyte® Liquid Bicarbonate Concentrate Due To Potential Health Risk 5/23/2014
FDA Warns CardiacAssist, Inc. On Unreported Patient Death 5/22/2014
Ventlab Issues A Nationwide Recall Of Ventlab Resuscitator Bags Due To Possible Health Risk 5/16/2014
Johnson & Johnson (JNJ)'s Ethicon, Inc. (JNJ) Suspends Device Sales After FDA Warning 5/15/2014
FDA Slaps Datascope, Inc./MAQUET's Intra-Aortic Balloon Pumps (IABPs) With A Class 1 Recall 5/13/2014
Cook Medical's Lead Extractor Pulled From Market For Uncleared Updates 5/9/2014
Alere Inc. (ALR) Initiates Urgent Recall Of Some PT/INR Testing Strips 5/6/2014
FDA Warns On Hospira, Inc., Abbott Laboratories (ABT) Infusion Pump Recall 5/5/2014
Baxter International, Inc. (BAX) Pump Recall Gets FDA's Highest-Risk Label Following 9 Severe Injuries 5/5/2014
HeartWare (HTWR) Issues Voluntary Device Correction For HeartWare® Batteries 5/1/2014
Johnson & Johnson (JNJ) Halts Sale Of Device Used In Fibroid Surgery 5/1/2014
InspireMD Ltd. Pulls MGuard Prime EPS Stent, Suspends U.S. Trial 5/1/2014
FDA Bumps HeartWare (HTWR)'s Recall To Highest-Risk 4/30/2014
Stop Using Shasta GenStrip Glucose Test Strips: FDA 4/30/2014
Decision Diagnostics Responds To Shasta Technologies FDA Safety Warning Letter 4/30/2014
Health Canada's Medical Device Bureau Completes Evaluation Of Solos Endoscopy, Inc. (SLSE.PK)'s Endoscopic Instruments For Canada 4/30/2014
Another Recall For Spacelabs Healthcare's Arkon Anesthesia System 4/21/2014
Endo Health Solutions Inc. (ENDP) Unit Receives FDA Warning Letter Tied To Form 483 Notice 4/17/2014
New Warnings For Medtronic, Inc. (MDT)'s Paradigm Insulin Pumps 4/15/2014
Covidien plc (COV) Recalls Its Pipeline™, Alligator™ Brain Aneurysm Devices 4/11/2014
Draeger Recalls Ventilators Over Battery Issues 4/4/2014
Thoratec Corporation (THOR) LVAD Recall Gets Class I Status 4/2/2014
GE Healthcare Recalls Hundreds Of Baby "Warmers" In China Over Safety Fears 4/1/2014
FDA Slaps DexCom With Warning Over Deficiencies In Medical Device Reports 3/25/2014
Playtex Recalls Breast Pump Adapters Over Electrical Shock Risk 3/21/2014
Abbott Diagnostics Recalls Blood Glucose Meters Over False Readings 3/18/2014
McKesson Technologies Inc. Anesthesia Care Recalled Over Patient Data Issues 3/18/2014
Merit Medical Systems, Inc. (MMSI) Gets FDA's Highest-Risk Label Over Hospira, Inc. Injections 3/14/2014
Hospira, Inc. Racks Up Another Warning Letter 3/13/2014
Fitbit Recalls Force Activity-Tracking Wristband Due To Risk Of Skin Irritation 3/13/2014
Philips Healthcare Ventilator Recalled Over Power Management Flaw 3/10/2014
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
GE Healthcare Recalls Infant Resuscitators over Serious Assembly Error 3/6/2014
Four Deaths Linked To Thoratec Corporation (THOR)'s Heartmate II® LVAS Pocket System Controller 3/5/2014
Medline Industries, Inc. Guidewires Recalled Over Serious Coating Problems 3/3/2014
St. Jude Medical (STJ) Warns About Surgery With Older Pacemakers 2/26/2014
New Breast Implant Recall In The EU Prompts Need For VeriTeQ Corporation (VTEQ)’s Device Traceability Technology 2/24/2014
FDA Warns Baxter International, Inc. (BAX) On Homechoice Dialysis System, Infusion Pump 2/21/2014
Philips Respironics Initiates Recall Of Trilogy Ventilator 2/20/2014
Amgen (AMGN) Hit With FDA Warning Over Drug-Device Combos 2/17/2014
Baxter Healthcare Corporation (BAX) Facility Gets Another FDA Warning Letter 2/17/2014
Teleflex Medical Voluntary Recalls ISIS™ HVT™ Tracheal Tubes Cuffed With Subglottic Secretion Suction Port 2/13/2014
HeartSine Technologies, Inc Warned By FDA For Medtech Reporting, Tracking Violations 2/13/2014
Johnson & Johnson (JNJ)'s Codman Neuro Recall Elevated To High Risk Class I 1/23/2014
Potentially Fatal Complication Found In Heart Valve Manufactured By Sorin Group S.p.A. (SRN) 1/22/2014
Tandem Diabetes Care Widens Recall Of Insulin Pump Cartridges 1/21/2014
FDA Dings Philips On InnerCool RTx Component Recall 1/16/2014
Software Glitch In Covidien (COV) Ventilator More Serious Than Thought, Could Be Deadly: FDA 1/15/2014
Tandem Diabetes Care Recalls Some T:slim Insulin Pump Cartridges 1/13/2014
FDA Slaps Covidien plc (COV) Ventilator With A Class I Recall Tag 1/10/2014
OraSure Technologies, Inc. (OSUR)'s DNA Genotek Slapped WIth A Warning Letter From The FDA 1/7/2014
Nipro Diagnostics, Inc. Initiates Voluntary Recall Of Certain TRUEbalance And TRUEtrack Blood Glucose Meters 1/3/2014
GE Healthcare's Vital Signs Devices Takes Action After Discovering Potential Health Risk From CO2 Multi Absorber 12/31/2013
FDA: Intuitive Surgical, Inc. (ISRG)'s da Vinci Surgical Robots Slapped With Class II Recall 12/19/2013
FDA Warns On Atossa Genetics, Inc. (ATOS)'s Aspirate Test For Breast Cancer 12/16/2013
FDA Warns Of Problems With Philips Healthcare's Heart Devices 12/4/2013
Intuitive Surgical, Inc. (ISRG)'s Robots May Stall In Surgery 12/4/2013
Abbott Diabetes Care (ABT) Recalls Blood Glucose Test Strips 12/3/2013
Hospira, Inc. (HSP) GemStar Pump System Gets Deadly Recall From The FDA 11/26/2013
FDA Warns Of Heart Risks With Astellas Pharma Inc. (ALPMY) Stress Test Chemicals 11/21/2013
Recalled Medtronic, Inc. (MDT) Guidewires Potentially Fatal: FDA 11/18/2013
Maker Of Recalled Breast Implants, Poly Implant Prothese, On The Hook For Damages 11/15/2013
Atossa Genetics, Inc. (ATOS) Slapped With Class 1 Recall, Marketed Product Without Approval Or Clearance 11/13/2013
FDA Hits Baylis Medical's TorFlex Transseptal Guiding Sheath Kit With Class I Recall 11/7/2013
Edwards Lifesciences Corporation (EW)'s EMBOL-X Glide Protection System Slapped With Class 1 Recall Over Deformed Tips 11/5/2013
Nephros Inc. (NEP) Plummets 68% on Filter Recall 10/31/2013
PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve 10/31/2013
King Systems Slapped With FDA Warning Letter 10/30/2013
GE Healthcare's Ventilator/Anesthesia Machines Slapped With Class 1 Recall by FDA 10/28/2013
Novo Nordisk A/S (NVO) Recalls Batches of FelxPen, Penfill Insulin in Europe 10/25/2013
U.K. Healthcare Regulators Warn of "Buckling" Becton Dickinson AG Catheters 10/24/2013
Medtronic, Inc. (MDT) Recalls Dilation Catheters Over Labeling Issue 10/23/2013
H&H Medical's Emergency Crichothyrotomy Kit Whacked With Class 1 Recall: FDA 10/23/2013
CareFusion 211 Slapped With FDA Warning Third Time This Year 10/22/2013
FDA Slaps Class I Recall on C.R. Bard's LifeStent Solo Vascular Stent 10/21/2013
FDA Warns of Small Risk With St. Jude Medical (STJ)'s Amplatzer Heart Device 10/18/2013
HeartSine Technologies, Inc Recalls Some PDU400 Defibrillators 10/17/2013
The Real Erin Brockovich Takes on Bayer AG (BAYN.DE)'s Birth Control 10/17/2013
Voluntary Field Corrective Action Issued for GE Healthcare’s Engström Ventilator and Aespire View, Aisys, and Avance Anesthesia Machines 10/16/2013
Globus Medical, Inc. (GMED) Reveals FDA Warning Letter Over MicroFuse Putty 10/15/2013
Draeger Issues an Update on Its Voluntary Recall of Fabius Anesthesia Machines 10/8/2013
CareFusion Corporation Provides Update on Voluntary Recall of AVEA® Ventilator 10/1/2013
Integra LifeSciences Holdings Corporation (IART) Resolves Violations at New Jersey Manufacturing Facility 9/26/2013
Baxter International, Inc. (BAX) Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps 9/20/2013
More Fall Concerns for Large Imaging Systems as Philips Healthcare Issues Warning 9/20/2013
GE Healthcare Issues Another Imaging System Fall Warning After Discovering Missing Screws 9/19/2013
HeartSine Technologies, Inc Issues Global Correction of Samaritan® 300/300P PAD 9/17/2013
Siemens Healthcare Diagnostics Recalls MicroScan Synergies Plus® and RapID/S plus Gram Negative Panels 9/17/2013
RTI Surgical (RTIX) Spikes After Dodging FDA Warning 9/16/2013
Rented Medtronic, Inc. (MDT) Equipment May Have Exposed 13 Patients With Fatal Brain Disease 9/6/2013
Defect Leads Siemens (SI) to Recall 78,000 MicroScan Panels 9/5/2013
Stryker Corporation  (SYK) Recalls Spine Surgery Device, Tagged With FDA's "Deadly" Label 8/29/2013
FDA Hits Fresenius AG With 3rd Warning Letter This Year 8/27/2013
FDA Warns on Oxygen Chamber Scams 8/26/2013
FDA Should Warn Against Prolonged Use of Plavix for Stent Patients, Says U.S. Consumer Group 8/22/2013
Covidien plc (COV) Recalls Some Prefill Flush Syringes 8/20/2013
Recall: FDA Sounds the Alarm on Hospira, Inc. (HSP) Blood Kits After 1 Patient Dies 8/16/2013
CircuLite Warns on Synergy Heart Pumps After Receiving Cannula Fracture Reports 8/16/2013
Menarini Group's Glucose Testing Strips Recalled Over False Reading Worry 8/16/2013
LMT Surgical Recalls Shoulder Implants Amid 3% Fracture Rate 8/15/2013
Aimedics Recalls All HypoMon Sleep Glucose-Monitoring Devices 8/14/2013
FDA Issues Class I Recall on Infusion Technology Made by IRadimed Corporation 8/14/2013
Class 1 Recall Issued to Cordis Corporation (JNJ)'s Optease Retrievable Inferior Vena Cava (IVC) Filter 8/8/2013
Class 1 Recall Issued for CareFusion Corporation's - Alaris PC Unit (Model 8015) With Version 9.12 Keyboard Processor 8/8/2013
DePuy Orthopaedics, Inc. (JNJ)'s Limb Preservation System Slapped With Class 1 Recall 8/2/2013
Nova Biomedical Recalls Glucose Test Strips 7/31/2013
Hospital Death Forces Recall of GE Healthcare's Nuclear Medicine Machines 7/30/2013
Johnson & Johnson (JNJ) Subsidiary Gets Class I Recall for Implantable Infusion Pumps 7/26/2013
LeMaitre Vascular, Inc. Graft Recall Gets FDA's Highest Warning 7/25/2013
FDA Slaps Ohio-Based Bryan Medical With Its Highest-Risk Recall 7/25/2013
Stryker Corporation  (SYK) Pulls Spinal Devices Off the Shelves Following Failure Reports 7/24/2013
DePuy, Inc. Warns Surgeons on Fracture Risk in Limb Preservation System 7/24/2013
Philips Healthcare HeartStart MRx Defibrillator Recall Affects 65K Devices Worldwide 7/18/2013
Medtronic, Inc. (MDT) Recalls Implantable Pacemakers Over Manufacturing Concerns 7/16/2013
FDA Recalls Medtronic, Inc. (MDT) Insulin Pumps Recall Over Insulin Worries 7/15/2013
Intuitive Surgical, Inc. (ISRG) May Not Have Tested Devices Properly 7/12/2013
FDA Puts Highest-Risk Label on Verathon Inc.'s Reusable Laryngoscope Recall 7/12/2013
Integra LifeSciences Corporation (IART) Recall Affects Medtronic, Inc. (MDT)'s Infuse Kits 7/3/2013
Medtronic, Inc. (MDT)'s SynchroMed Linked to 14 Deaths 6/28/2013
FDA: Intuitive Surgical, Inc. (ISRG) Failed to Report Warning 6/26/2013
FDA Bars Medtronic, Inc. (MDT) Catheter Imports Amid "Serious" Miscues 6/26/2013
Medtronic, Inc. (MDT) Recalls Surgical Breathing Tube 6/24/2013
Respironics, Inc. (RESP) Ventilators Recalled for Software Malfunctions 6/21/2013
Fresenius Medical Care Receives FDA Warning Letter 6/19/2013
St. Jude Medical (STJ)'s Durata Defibrillator "Immune" to Riata Flaws? 6/19/2013
Endologix Inc. AFX Introducer System: Class 1 Recall - Reports of Dilator Breaking During Procedures 6/18/2013
FDA Urges Protection of Medical Devices From Cyber Threats 6/14/2013
Cook Medical: Trouble Ahead Following Zilver PTX Stent Recall 6/12/2013
Labeling Issues Plague Boston Scientific Corporation (BSX)'s Balloon Dilators 6/11/2013
Intuitive Surgical, Inc. (ISRG) Ships New Surgical Scissors Following Crack Warning 6/6/2013
Nephron Pharmaceuticals' EZ Breathe Atomizer Tagged With Class 1 Recall 6/5/2013
FDA Warns CooperSurgical, Inc. About Texas Manufacturing Plant 5/31/2013
FDA Warns Edwards Lifesciences (EW) on Quality 5/30/2013
Boston Scientific Corporation (BSX) Wants Major Changes to Recall/Enhancement Draft Guidance 5/30/2013
U.K. Regulators Warn on Unomedical's Endotracheal Tubes 5/29/2013
Chinese Regulators Warn of Software Glitch in Philips Healthcare's Pinnacle3 Radiation Therapy Software 5/29/2013
FDA Gives Cook Medical's Zilver PTX Drug-Eluting Peripheral Stent a Serious Warning 5/28/2013
Symbios Medical Products Recalls GoPump and GOBlock Kits Following Patient Complaints 5/23/2013
FDA Pins Abbott Diabetes Care (ABT)'s FreeStyle InsuLinx Blood Glucose Meters With Class 1 5/20/2013
Roche (RHHBY) Recalls CoaguChek Monitors 5/20/2013
Johnson & Johnson (JNJ) to Discontinue Metal-on-Metal Hip Products 5/17/2013
FDA Warns Hospira, Inc. (HSP) -- Again 5/16/2013
Maquet Cardiovascular LLC's Class I Ventilator Battery Recall Affects 90k Units 5/16/2013
Australia Recalls a Johnson & Johnson (JNJ) Device 5/14/2013
Intuitive Surgical, Inc. (ISRG) Warns on Da Vinci Scissor Crack Risk 5/13/2013
FDA Warns Covidien (COV)'s Stolen Stapler Reloads Up for Sale Before Sterilization 5/8/2013
Cardinal Health, Inc. (CAH) Recalls Pre-Assembled Filter and Anesthesia Circuit in Packs 5/7/2013
Medtronic, Inc. (MDT) Warns on Wire Damage Risk With Deep-Brain Stimulation Implants 5/3/2013
Cook Medical Initiates Global Recall of Its Zilver® PTX®Drug Eluting Stent 4/25/2013
GE Healthcare Warns on Certain Giraffe Infant Care Systems 4/24/2013
Covidien plc (COV) Recalls Power Pac Batteries for Newport™ HT70 and HT70 Plus Ventilators 4/19/2013
FDA Cites Baxter Healthcare Corporation (BAX) for Selling Pump Without PMA 4/17/2013
Abbott Laboratories (ABT) Recalls FreeStyle InsuLinx Glucose Meters 4/15/2013
Integra LifeSciences Corporation (IART) Recalls Some Collagen Items 4/12/2013
HeartWare (HTWR) Device Malfunction Led to Death, FDA Reports 4/11/2013
Recall: Hoya Surgical Optics, Inc. Pulls Intraocular Lenses 4/11/2013
CareFusion Corporation Hit by Another Warning for Its Alaris Infusion Pump 4/9/2013
A Real False Alarm: Johnson & Johnson (JNJ) Recalls Another Product 4/8/2013
Spacelabs Healthcare Pulls Anesthesia Workstations Over Excess CO2 Risk 3/28/2013
Stereotaxis, Inc. (STXS) Receives Delisting Warning From Nasdaq 3/26/2013
Asia Recalls Merck Sharp & Dohme (MRK)'s Contraceptive Devices 3/26/2013
LifeScan, Inc.'s OneTouch Verio IQ Blood-Glucose Meters Recalled 3/25/2013
NuVasive, Inc. (NUVA) Ticketed With FDA Warning Letter 3/20/2013
Symbios Medical Products' PumpKit Slapped With Recall 3/19/2013
Vascular Solutions (VASC) Issues Recall on Guardian® II and Guardian II NC Hemostasis Valves Due to Risk of Air Embolism 3/19/2013
Fresenius Medical Care AG & Co. KGaA (FMS) Reveals FDA Warning Letter 3/15/2013
Johnson & Johnson (JNJ) Exec Says Hip Implant Was Recalled for Clinical Reasons 3/14/2013
FDA Warns Stryker on Quality Issues, Marketing Practices 3/12/2013
Honey, Pass the… Uh-Oh, Johnson & Johnson (JNJ) Recalls K-Y Jelly 3/8/2013
FDA Issues Warning Letter to Medtronic, Inc. (MDT) CoreValve Investigator 2/28/2013
FDA Slaps Lumenis Ltd. (LUME) Recall With Class I Status 2/26/2013
Johnson & Johnson (JNJ) Recalls Knee Replacement Device 2/25/2013
FDA Sends Warning Letter to Atossa Genetics, Inc. (ATOS) 2/25/2013
FDA Cites Alcon, Inc. (ACL) for Improperly Marketing Laser 2/22/2013
Johnson & Johnson (JNJ)'s Toxicologist Says Metal From Recalled Hip Harmless 2/22/2013
DePuy Orthopaedics, Inc. (JNJ) Knew of Problems Well Before Recall 2/19/2013
FDA Sends Warning Letter to Rigid FX Orthopedics for the Clearview Wrist Fixation System 2/15/2013
FDA Lays Down 2 Warning Letters for Bacterin International, Inc. 2/15/2013
Johnson & Johnson (JNJ) Warns of Safety Risk for 7,500 Non-U.S. Hip Implants 2/15/2013
Hospira, Inc. (HSP) Gets FDA Notice Over Medical Device Problems 2/14/2013
FDA Slaps Highest Risk Label on St. Jude Medical (STJ)'s Amplatzer TorqVue FX Recall 2/13/2013