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Medical Dev. & Diag. - Recalls and Warnings
Royal Philips Electronics N.V. (PHG) Issues a Set of Urgent Safety Notice for Allura Systems 2/2/2016
Johnson & Johnson (JNJ)'s Ethicon (JNJ) Recalls Gynecare Thermachoice III Cath on Shelf Life Issues 2/2/2016
Federal Regulators Find Conditions at Theranos Lab That Pose "Immediate Jeopardy to Health" 1/29/2016
Feds Find "Serious Deficiencies" at Theranos Lab 1/26/2016
FDA Slaps St. Jude Medical (STJ)'s Optisure Dual Coil Defibrillation Leads with a Class I Recall 1/25/2016
Fourth Patient Treated with Carmat (ALCAR.PA)'s Artificial Heart Dies 1/22/2016
LifeWatch Corp to Suspend Home Sleep Testing Services 1/19/2016
FDA Slaps BrainLAB AG's Cranial IGS System with a Class I Recall 1/18/2016
Olympus (OCPNF) Recalls Scopes Blamed for Deadly Superbug Outbreak 1/18/2016
Former C.R. Bard Employee Says 510(k) Process May Be to Blame for Vena Cava Filter Deaths 1/14/2016
FDA Tags Stryker's Pleural Drainage Device Recall a Class I 1/13/2016
PA Rep Wants the FDA to Launch Criminal Probe into Morcellator Deaths 1/7/2016
Boston Scientific (BSX) Recalls Chariot Guiding Sheaths After Pieces Broke Off in Patients 12/10/2015
Olympus (OCPNF) Recalls Select EndoEye HD II Endoscopes Over Heat Issue 12/9/2015
Chinese Customs Officers Seize 120,000 Fake Face Masks Supposedly Made By 3M Company (MMM) 12/9/2015
Insulet (PODD) Voluntarily Recalls Omnipods on Needle Deployment Issue 12/4/2015
FDA Slaps a Class II Recall on Three of Royal Philips Electronics N.V. (PHG)'s Allura Xper Vascular X-ray Systems 12/3/2015
Medtronic (MDT) Recalls Nearly 97,000 Insync III Pacemakers Due to Battery Issue 12/2/2015
FDA Warns A-1 Engineering Over Lack of Approval, Demands Halt to Sales 11/30/2015
Boston Scientific (BSX)'s Artery-Clearing Tools Recalled After Patient Death 11/30/2015
MiMedx Awarded 12 New U.S. Patents YTD 2015 With Four Awarded For Its Amniotic Membrane Allografts And Eight Awarded For Its CollaFix Technology 11/20/2015
Boston Scientific (BSX) Recalls Atherectomy Components 11/18/2015
AngioDynamics (ANGO) Announces Resolution of FDA Warning Letter 11/17/2015
FDA Orders Recall of All Custom Ultrasonics' Endoscope Reprocessors 11/16/2015
FDA Sends Warning Letter to DNA4Life Over Consumer Gene Tests 11/10/2015
Quest Medical Issues Recall for Open Heart Surgery Drug Delivery Devices 11/2/2015
FDA Requests Aros Surgical to Cease Sales of Its Surgical Sutures, Micro Anastomosis Clamps 10/30/2015
FDA Reports From Lab Visits Highlight Problems at Theranos 10/29/2015
Walgreens Halts Expansion of Theranos Blood Testing Centers Until Questions Gets Answered 10/27/2015
European Medicines Agency Recommends Suspension Of Medtronic (MDT)'s Implant Inductos 10/23/2015
Merge Healthcare (MRGE) Receives Warning Letter on Device by U.S. Health Agency 10/14/2015
Cook Medical Expands Recall of Select Sizes of Beacon Tip Angiographic Catheters 10/12/2015
Sientra (SIEN) Temporarily Halts U.S. Sale of Devices Manufactured by Silimed 10/12/2015
Needle Maker International Medical Development Hit with a FDA Warning 10/8/2015
Sientra (SIEN)'s Silicon Implant Supplier in Brazil Shut Down by Regulators 10/5/2015
FDA Slaps St. Jude Medical (STJ) with Warning Letter for Atlanta Facility 10/5/2015
Women Ask the FDA to Withdraw Bayer (BAY)'s Controversial Contraceptive Essure 9/25/2015
FDA Berates Sironis for Running Unapproved Trial 9/25/2015
FDA Hits Pearson With Warning Over ADHD Device Claims 9/25/2015
Pathway Genomics's Cancer Blood Test May Harm Public, FDA Says 9/25/2015
Sale of Silimed's Breast Implants Suspended Amid Contamination Fears 9/24/2015
Complaints for Bayer AG (BAYZF)'s Sterility Device Spike Nearly 1,400% in Three Years 9/22/2015
FDA Expands Warnings About Contaminated Medical Scopes 9/18/2015
Faulty Batteries Prompts Recall of Two Draeger Medical, Inc. Ventilators Used in Pediatrics 9/9/2015
Teleflex Incorporated (TFX) Announces Worldwide Voluntary Recall Of HUDSON RCI SHERIDAN SHER-I-BRONCH Endobronchial Tube 9/8/2015
Medtronic (MDT)'s Breathing Device Recalled for Second Time in a Year 9/3/2015
Insulet (PODD) Recalls More Than 400,000 OmniPods 8/31/2015
ConforMIS Initiates Voluntary Recall of iUni, iDuo and iTotal Systems 8/31/2015
FDA Slaps CareFusion, Elite Biomed Class I Recalls for Drug Pumps 8/28/2015
Teleflex Medical Slammed With Another Class 1 Recall 8/27/2015
Scope Maker Olympus (OCPNF) Investigates SoCal Infections, Denies FDA Violation 8/21/2015
FDA Slaps Warning on Transdermal Cap Over a Handful of Operational Issues 8/20/2015
FDA Issues Recall After Western/Scott Fetzer's Explosive Oxygen Unit Killed One Person and Injured Another 8/19/2015
CareFusion Hit with New Class I Recall 8/18/2015
Blackberry Infusion Pump "Hack" Was A Sham, Says Hospira 8/17/2015
Medtronic (MDT) Recalls Loading System for EnVeo R Loading System 8/7/2015
Cook Medical Recalling Select Beacon Tip Angiographic Catheters 8/5/2015
Hospira's Hospital Drug Pump Can Be Hacked Through Network, FDA Warns 8/3/2015
Medtronic (MDT) Warns Customers on Potential Minimed Pump Glitch 7/29/2015
FDA Slaps Alphatec Spine With Warning Letter Over SoCal Plant 7/24/2015
C. R. Bard, Inc. (BCR) Discloses FDA Warning Letter Over IVC Filter Retrievers 7/22/2015
Why Medtronic (MDT) Is Facing a Major Tracheostomy Tube Recall 7/16/2015
Software Glitch Prompts a Class I Recall of Hamilton Medical Ventilator 7/15/2015
Consumer Watchdog Asks FDA to Revoke Approval of Sanofi (SAN.PA)'s Seprafilm 7/8/2015
Teleflex Incorporated (TFX) Recalling Its Hudson RCI Manual Resuscitator 7/7/2015
MAQUET Recalls Flow-i Anesthesia Systems 7/2/2015
Zimmer (ZMH) Slammed With a Serious Hip Replacement Part Recall 7/1/2015
Medtronic (MDT) Implements Worldwide Voluntary Recall For Certain Lots Of Neonatal And Pediatric Tracheostomy Tubes 6/24/2015
Will HeartWare (HTWR)'s Recall Pains Ever Stop? 6/18/2015
Health Canada Release: Advisory - Two Lots Of Sanofi-Aventis (Canada)'s Allerject (0.15 Mg / 0.15ml Auto-Injector) For Use In Children Recalled Due To Manufacturing Defect 6/15/2015
FDA Slaps Warning Letter on Insulet Corporation (PODD) Over Some Insulin Pumps 6/12/2015
FDA Warns Allergan (AGN) Over Marketing of Seri Scaffold 6/11/2015
Baxter International (BAX) Says Packaging Change Caused Serious Recall of Peripheral Vascular Patch 6/9/2015
Smith & Nephew Inc. (SNN) Yanks Some Hip Components From Market 6/9/2015
CareFusion Provides Update On Voluntary Global Recall Of AVEA Ventilator 5/27/2015
Medtronic (MDT)'s Recently Approved Varicose Vein Device Slapped With Recall 5/19/2015
FDA Warns On Hospira's Infusion Pumps After Researcher Reveals Security Flaws 5/15/2015
FDA Slaps Smith & Nephew Inc. (SNN) With Warning Letter for QC Violations at Massachusetts Site 5/7/2015
Fifth Death Tied to Bayer HealthCare (BAY)'s Controversial Birth Control Device 4/29/2015
Alert: Bednest Ltd. Recalls Bedside Cribs 4/28/2015
FDA Slaps MAQUET's TigerPaw With a Class I Recall Tag 4/28/2015
FDA Orders Medtronic (MDT) to Stop Manufacturing Pain Drug Pump 4/28/2015
Zimmer (ZMH) Voluntary Recalls Persona Trabecular Metal Tibial Plate Knee Implant 4/23/2015
FDA Slaps Stanmore Implants With Import Ban 4/20/2015
Hospira Slapped Again By the FDA for Plant Problems 4/16/2015
Intuitive Surgical (ISRG) Deals With a Global Recall of 440K Microtek Surgical Drapes 4/13/2015
Zimmer (ZMH) Voluntarily Recalls Knee Device Persona® Trabecular Metal 4/7/2015
Medtronic (MDT) Slapped With Class 1 Recall Involving Steerable Sheath 3/20/2015
Mounting Hospira Recalls and Plant Woes Will Soon be Pfizer (PFE)'s Problem 3/12/2015
Sunshine Heart Halts Trial Enrollment After Patient Deaths 3/9/2015
FDA Clears One Hospira Plant But Flags Another 3/5/2015
Single Human Error Prompts GE Healthcare to Issue Warning on 30 Years Worth of MRI Scanners 3/2/2015
Alert: Philips Lifeline Recalls The Non-Breakaway Neck Cord Version Of Lifeline Personal Help Button Pendants 2/23/2015
HeartWare (HTWR) Recalls Certain Older HeartWare® Clinical Trial Controllers 2/23/2015
FDA Issues Class 1 Recall for 13,000 GE Healthcare MRI Systems 2/20/2015
FDA Knew Devices Made by Olympus Corporation (OCPNF), Pentax Corporation and More Spread Fatal Superbug But Did Nothing About itTill Now 2/20/2015
FDA Orders MAQUET to Temporarily Suspend Manufacturing at New Hampshire Facility 2/12/2015
FDA Slaps Another Warning on STAAR Surgical Company (STAA)'s California Plant 2/12/2015
FDA Hits Covidien (COV)'s Peripheral Infusion Systems With Class 1 Recall 2/11/2015
Nanosphere, Inc. Announces Fourth Quarter And Full Year 2014 Preliminary Top Line Results, Director And Management Changes And Receipt Of FDA Warning Letter 1/29/2015
U.K. Warns On Smith & Nephew Inc. (SNN)'s Wound Care Device 1/27/2015
Alere Inc. (ALR) Issues Class I Recall for Blood Clot-Testing Products 1/16/2015
Another Recall For Covidien plc (COV)'s Nellcor Ventilator Biz 1/7/2015
FDA Hits Halyard Health's KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes With a Class 1 Recall 1/2/2015
Royal Philips Electronics N.V. (PHG)'s Redesign Prompts Another Class I Recall 12/31/2014
FDA Slaps Customed's Surgical Convenience Packs With a Class 1 Recall 12/30/2014
Royal Philips Electronics N.V. (PHG) Defibrillator Updates Spur ConMed Corporation (CNMD) Electrode Recall 12/8/2014
Alere Inc. (ALR) Initiates Voluntary URGENT CORRECTION For Use Of Alere INRatio® and INRatio 2 PT/INR Monitor System 12/8/2014
Royal Philips Electronics N.V. (PHG) Widens Class I Recall Of Infant Hospital Pillows 12/3/2014
Baxter International, Inc. (BAX) Initiates Voluntary Recall Of One Lot Of Highly Concentrated Potassium Chloride Injection In The U.S. Due To Mislabeled Overpouch 11/21/2014
Philips Respironics Esprit Ventilator Recall Is Class I 11/21/2014
Stericycle ExpertSOLUTIONS Release: Recall Challenges Ahead For Medical Device Sector 11/20/2014
Philips Healthcare (PHG) Announces Recall Of Children's Medical Ventures Gel-E Donut / Squishon 2 Products 11/17/2014
Covidien (COV)'s Puritan 980 Ventilator Slapped With A Class 1 Recall 11/10/2014
Hospira, Inc. Hit With Another Serious Infusion Pump Recall 11/7/2014
Google Inc. Glass May Cause Blind Spots 11/5/2014
FDA Warns Cook Medical On Problems At Indiana Plant 10/30/2014
CareFusion Corporation Struck With Another Class I Recall 10/10/2014
Teleflex Incorporated (TFX) Recalls Hudson RCI® Pediatric Anesthesia Breathing Circuits 10/3/2014
FDA Slaps Valeant (VRX) With A Warning Letter 10/1/2014
Mylan Pharmaceuticals, Inc. (MYL) Recalls Nitroglycerin Spray Due To Defective Pump 9/22/2014
Cook Medical's CloverSnare Recall Gets FDA's Highest-Risk Label 9/8/2014
IRadimed Corporation Hit With FDA Warning Letter 9/3/2014
Johnson & Johnson (JNJ)'s DePuy Synthes Gets Highest-Risk Warning After 15 Complaints 9/3/2014
SAM Medical Products Recalls Accessory (Axilla) Strap For The SAM Junctional Tourniquet 9/2/2014
Smiths Medical, Inc. Recalls Certain Portex® Endotracheal Tube Holders 9/2/2014
FDA Slaps Vention Medical With Warning Letter Over Costa Rica Plant 8/29/2014
Smiths Medical, Inc. Issues Urgent Medical Device Recall of Certain Portex® Endotracheal Tube Holders, 2.5mm and 3.0mm 8/21/2014
FDA Approves Changes To Covidien plc (COV) Recalled Devices 8/21/2014
Cook Medical Recalls CloverSnare Vascular Retrieval Snare Due To Embolization Concerns 8/20/2014
Masimo Corporation (MASI) Affirms FDA Warning Letter Over Pronto 7 Monitor 8/20/2014
Enhancement Medical Recalls All Intranasal Splint Over Manufacturing Concerns 8/15/2014
FDA Warns Of Danger From Popular Injectable Filler 8/11/2014
Doctors Chime In On Johnson & Johnson (JNJ) Recall 8/4/2014
Warning: Merck Canada Advises Some Women To Avoid Using Its Product 8/1/2014
Johnson & Johnson (JNJ) Ask Doctors To Return Hysterectomy Device Due To Cancer Risk 8/1/2014
FDA Warns CareFusion Corporation Over Modified Devices, Quality Control 7/25/2014
BroadMaster Bio-Tech Corp.'s Glucose Test Strips Recall Reaches Class I Level 7/24/2014
Baxter International, Inc. (BAX) Initiates Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter 7/23/2014
United Therapeutics Corporation (UTHR) Release: Devices Used with Tyvaso Therapy Being Recalled 7/23/2014
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