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Clinical - Recalls and Warnings
Mauna Kea Technologies: PERSEE Study Demonstrates Applicability Of Cellvizio In Surgical Interventions For Digestive Cancers, Triggering Milestone Payment From BpiFrance 11/30/2016
3 Fires Linked to Medtronic (MDT)'s Bellco Formula Dialysis Device 11/29/2016
Bay Area's SentreHEART Recalls Findrwirz Guidewire System Over Coating Separation Issues 11/23/2016
Sanofi Pasteur (SASY.PA) Abandons Bladder Cancer Drug 11/18/2016
Vistin Pharma: Metformin Production Temporarily Halted Due to Unscheduled Maintenance Stop 11/18/2016
Smith & Nephew plc (SNN) Recalls Modular SMF, Modular Redapt Hip Implants 11/17/2016
Renowned Cardiologist Calls for a Halt to Boston Scientific (BSX)'s Watchman Implants 11/11/2016
Teleflex Medical Recalls Faulty Nasal Delivery Devices Used to Rescue People Who Have Overdosed on Opiods 11/11/2016
Valeant (VRX)'s Many Acquisitions Led to Manufacturing Issues, Says the FDA 11/9/2016
Two Deaths Linked to Bristol-Myers Squibb (BMY)'s Yervoy-Opdivo Combo 11/3/2016
More Deaths Linked to Medtronic (MDT) Infusion Pump 11/2/2016
Boston Scientific (BSX) Hits the Pause Button on Next-Generation Lotus Edge Replacement Heart Valve in Europe 11/1/2016
FDA Posts Another Recall for Medtronic (MDT)-HeartWare (HTWR)'s HVAD Over Issues With Loose Power Connectors 10/31/2016
FDA Warns US Specialty Formulations for Unsanitary Conditions 10/26/2016
GlaxoSmithKline (GSK) Yanks HPV Vaccine From U.S. Market 10/25/2016
Outside Firm Backs Claims St. Jude Medical (STJ) Heart Devices Can be Hacked 10/25/2016
HeartWare (HTWR) Recalling Some HVAD Pumps Over Design Problems 10/25/2016
Teleflex Inc. (TFX) Recalls Tracheostomy Sets Due to Disconnection Risk 10/24/2016
Teva (TEVA) Rallies Despite FDA Warning Letter 10/21/2016
The Other Side: The Patients Hurt by Theranos' Botched Blood Tests 10/21/2016
Stryker (SYK) Recalls Boston Scientific (BSX)'s Guider Guide Catheter 10/21/2016
Leonhard Lang GmbH and Welch Allyn's Serious Recall Involves Incompatible Defibrillator Electrodes 10/20/2016
FDA Finds 6 Problems at Akorn Pharma's Illinois Plant 10/19/2016
FDA Panel Expresses Concerns Over Allergan (AGN)-Serenity Drug for Nighttime Urination 10/18/2016
Medtronic (MDT) Issues Yet Another Recall for Pipeline Device 10/17/2016
Pfizer (PFE) Retracts 5 Articles Authored by Top Cancer Researcher Who Has Since Left the Company 10/14/2016
Deaths, FDA Warnings Push Hyland to Discontinue Infant Teething Medicines 10/13/2016
FDA Finds Link Between Contaminated Water at Pharmatech and a Multi-State Outbreak of B. Cepacia 10/13/2016
Medtronic (MDT) Calls Link to Faulty St. Jude Medical (STJ)'s Batteries Misleading, 'Uses Different Battery, With A Different Battery Design' 10/13/2016
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee 10/11/2016
Two Deaths Linked to St. Jude Medical (STJ)'s Heart Device Battery 10/11/2016
Vascular Solutions (VASC) Recalls More Than 15,000 Catheters 10/10/2016
Baxter International (BAX) Recalls Select IV Fluid Filters 10/7/2016
Johnson & Johnson (JNJ)'s Insulin Pump Vulnerable To Hacking 10/4/2016
Medtronic (MDT) Issues Urgent Safety Notices for Select ICDs, CRTds 9/30/2016
Medtronic (MDT) HeartWare (HTWR) Faces Two Class 1 FDA Recalls 9/30/2016
Sun Pharma (SUNPHARMA.NS), Lupin (LUPN.BO) Recall Over 41,500 Drug Bottles In U.S. 9/29/2016
Theranos's Arizona Lab Still Open Despite Violations 9/22/2016
FDA Slaps Ban On API Supplied By India’s Laxachem 9/20/2016
FDA Places Clinical Hold on AML Drug Co-Developed by Johnson & Johnson (JNJ) and Genmab A/S (GEN.CO) 9/20/2016
Flooding Halts Work at GlaxoSmithKline (GSK) Plant 9/16/2016
Virtus Pharmaceuticals Issues Voluntary Nationwide Recall Of Hyoscyamine Sulfate Due To Superpotent And Subpotent Results 9/15/2016
FDA Advisory Committees Recommend To Remove Boxed Warning In Labeling For Pfizer (PFE)’s Smoking Cessation Therapy, CHANTIX (Varenicline) 9/15/2016
The FDA Wants to Know if St. Jude Medical (STJ) Devices are Safe 9/13/2016
Novartis AG (NVS) Issues Voluntary Nationwide Recall Of Six Batches Of GlucaGen HypoKit (glucagon [rDNA origin] For Injection) Due To Detached Needles On The Syringe In The Kit 9/9/2016
FDA Slaps Warning on Frontida BioPharm Plant 9/7/2016
More Trouble for Theranos as FDA Discovers Company Cut Corners With Zika Test 9/1/2016
FDA Requires Strong Warnings For Opioid Analgesics, Prescription Opioid Cough Products, And Benzodiazepine Labeling Related To Serious Risks And Death From Combined Use 9/1/2016
ResMed (RMD) Recalls Astral Ventillators Due to Internal Battery Issues 9/1/2016
Holes Found in Report on St. Jude Medical (STJ) Device Security 8/31/2016
IMPAX Labs (IPXL) Issues Voluntary, Nationwide Recall For One Lot Of Lamotrigine Orally Disintegrating Tablet 200 Mg Due To The Potential For 100 Mg Blister Cards Being Packaged In 200 Mg Containers 8/29/2016
Embattled Theranos Plans to Appeal to Re-Open Its Lab in Newark, California 8/26/2016
FDA Slaps Warning on Sun Pharma (SUNPHARMA.NS)'s Former U.S. Facility for Releasing Drug Despite Contamination Issues 8/26/2016
St. Jude Medical (STJ) Stock Shorted on Heart Device Hacking Fears, St. Jude Responds 8/26/2016
Stryker (SYK)'s Sage Products Expands Med Wipes Recall Over B. Cepacia Contamination Concerns 8/24/2016
Sage Products, Inc. Expands Voluntary Worldwide Recall Of Specific Lots Of Topical Skin Products Due To Potential Microbial Contamination 8/22/2016
Electrical Fault Risk Leads HeartWare (HTWR) to Recall Some HVAD Implantable Heart Pumps 8/19/2016
19 Deaths Force Medtronic (MDT) to Warn Doctors on Heart Valve Delivery System 8/18/2016
Sagent Pharma Initiates A Nationwide Voluntary Recall Of Oxacillin For Injection, USP, 10 G Due To Presence Of Iron Oxide Particulate Matter 8/18/2016
FDA Hits 12 Medtech Firms With Warning Letters 8/18/2016
GlaxoSmithKline (GSK) Best-Selling Weight Loss Pill Cramped By Problematic Studies That Understated Its Harms 8/17/2016
Sage Products, Inc. Expands Voluntary Nationwide Recall Of Comfort Shield Barrier Cream Cloths Due To Microbial Contamination 8/15/2016
Cook Medical Issues Global Recall of Roadrunner UniGlide Hydrophilic Wire Guides Due to Raw Materials Issue 8/12/2016
French Government Denies Cover-Up of Birth Defects Study Related to Sanofi (SNY) Epilepsy Drug 8/11/2016
10,000+ Women Took Sanofi (SNY)'s Anti-Epilepsy Drug Despite Risk to Fetuses 8/10/2016
FDA Concerned Over Quality Issues at Alexion (ALXN)'s Soliris Facility 8/9/2016
Deficiencies Force Pfizer (PFE) to Shut Down Indian Facility Temporarily 8/8/2016
Pharmascience Inc. Voluntarily Recalls One Lot Of Pms-Atenolol 100mg Due To A Labelling Error 8/8/2016
Draeger Medical Recalls Ventstar Oxylog 3000 Pediatric Breathing Circuits 8/8/2016
FDA Warns Chinese Drugmaker Xiamen Origin Biotech Over Making False Statements to Regulators 8/5/2016
Children Hospitalized Over Inno Pharma's Super Strong Vitamin D Supplement 8/5/2016
Boston Scientific (BSX) Issues a Voluntary and Urgent Field Safety Notice for Select Lotus Valves 8/3/2016
CareFusion Recalls Select AVEA Ventilators Over Electrical Issues That May Cause an Unexpected Shutdown 8/1/2016
Teva (TEVA) Initiates Voluntary Nationwide Recall Of Seven Lots Of Amikacin Sulfate Injection USP 500mg/2 Ml (250 Mg/Ml) And 1 Gram/4 Ml (250 Mg/Ml) Vials Due To Potential Of Glass Particulate Matter 7/29/2016
Stryker (SYK) Recalling a Select Number of Reprocessed AngioDynamics (ANGO) Soft-VU Angio Caths 7/27/2016
Following Revelations of ‘Flawed Studies’ in Clinical Trials, EMA Recommends Suspending Drugs; Many of Which Belong to Novartis AG (NVS) and Teva (TEVA) 7/26/2016
Medtronic (MDT) Recalls Pacing Leads Due to Design Standards Blunder 7/21/2016
Employee Taken to Hospital After Genentech (RHHBY) Hazmat Spill in South San Francisco 7/18/2016
Indonesia Orders Overhaul Of Drug Agency After Fake Vaccine Scandal 7/15/2016
AB Science (AB.PA) Release: Action Plan Following Warning Letter Has Been Validated By FDA 7/14/2016
Sucampo (SCMP) Terminates Development of Cobiprostone Following Phase II Data 7/11/2016
NeoCoil Recalls Flex Speeder MRI Device Due to Burn Risk 7/7/2016
Medtronic (MDT) Warns on Wire Fracture Risk with Activa DBS Devices 7/5/2016
Trividia Health Initiates Voluntary Recall Of Certain Lots Of TRUEread, TRUEbalance, TRUEtrack & TRUEtest Blood Glucose Test Strips 6/29/2016
FDA Hits Medtronic (MDT)'s TYRX with Warning Over Anti-Bacterial Envelopes 6/23/2016
Big Pharmas Like Cipla (CIPLA), Pfizer (PFE) Among the 200 Under Inspection for Poor Drugs 6/21/2016
Phalanx Labs Banned from Shipping Products to U.S. After Refusing Inspection 6/21/2016
Stryker (SYK) Voluntary Recalls Select Target Nano Neuro Coils 6/21/2016
Johnson & Johnson (JNJ)'s Ethicon (JNJ) Recalls Physiomesh Flexible Composite Hernia Mesh 6/21/2016
Manufacturing Problems at Plant Disrupts Production of Some GlaxoSmithKline (GSK) Drugs 6/17/2016
Boston Scientific (BSX) Updates Warnings for Pelvic Mesh Products 6/15/2016
Teva (TEVA) Suspends Marketing for ZECUITY in the U.S. 6/13/2016
FDA Lifts Shipping Restrictions On Terumo’s Michigan Plant 6/13/2016
Embattled Theranos Catches a Break, Says Only 1% of Tests Have Been Voided or Corrected 6/7/2016
Zimmer Biomet Slapped with a FDA Warning Letter in May 6/6/2016
Medtronic (MDT) Recalls Midas Rex Sagittal Saws on Leaky Seals Risk 6/3/2016
Cardinal Health (CAH)'s Cordis (JNJ) Recalls Precise Pro RX Carotid Stent Over Separation Issues 6/1/2016
Bay Area's Intuitive Surgical (ISRG) Warns on Embolism Risk with Da Vinci Xi in Heart Procedures 6/1/2016
FDA Slaps Class 1 Tag on Medtronic (MDT)'s Capnostream Battery Pack Recall 5/31/2016
Bay Area's Intuitive Surgical (ISRG) Accused of Hiding More than 700 Injury Claims Involving Its Da Vinci Surgical Robot, Says Insurer 5/27/2016
French Authorties Blame Both Biotrial and Bial Over Fatal Drug Trial 5/24/2016
Abbott (ABT) Warns on Topera Catheter Spline Fracture Risk 5/24/2016
Europe Lifts Warning on Pfizer (PFE)'s Smoking Cessation Drug Champix 5/23/2016
FDA Slaps Warning on Eclipse Aesthetics' Micropen Personal Dermabrasion Device 5/23/2016
Embattled Theranos Tosses Out Two Years of Edison Blood Test Results 5/20/2016
FDA Warns Against Off-Label Use of Johnson & Johnson (JNJ)'s Nizoral Tablets to Treat Skin And Nail Infections, Linked to Patient Death 5/20/2016
Popular Pain Med Lyrica Linked To Major Birth Defects, Lausanne University Hospital Study 5/19/2016
Failure To Report Infuse Data Was Unintentional, Says Medtronic (MDT) 5/19/2016
FDA Lifts Recall On Custom Ultrasonics' Endoscope Reprocessors 5/17/2016
Sanofi (SNY) Recalls Some Batches of Combiflam in India 5/12/2016
FDA Warns of Potential Safety Risk for Eli Lilly (LLY) Antipsychotic Drug Zyprexa 5/11/2016
PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With A Single Recalled Lot Of Fresenius Kabi Sensorcaine-MPF (Bupivacaine Hcl) Due To The Presence Of Glass Particulate Matter 5/9/2016
Why B.Braun Medical's Latest Recall is a Serious One 5/6/2016
Otsuka America Pharma's Abilify Can Cause Urges to Gamble, Eat, Shop, Have Sex: FDA 5/5/2016
Cook Medical Recalls Catheters with Beacon Tip Technology 5/4/2016
Claims Against Johnson & Johnson (JNJ)'s Talcum Powder Gets Alarming 5/3/2016
Federal Health Regulators Release Lightly Redacted Theranos Report with More Details 5/2/2016
Merit Medical (MMSI) Looks to Take Advantage of Rival Cook Medical's Catheter Recall 5/2/2016
Halyard Health Rejects 60 Minutes Allegations Regarding Safety of Surgical Gowns 5/2/2016
Heritage Pharmaceuticals Issues Product Safety Warning Due To Reported Sales Of Counterfeit Drug Product Labeled As BiCNU (Carmustine For Injection) 100mg Outside Of The United States 4/29/2016
Study Reveals More Than One-Third of Hip Implants Made by Johnson & Johnson (JNJ)'s DePuy Synthes Were the Wrong Size 4/29/2016
Fresenius Kabi AG Issues Voluntary Nationwide Recall Of Sensorcaine-MPF (Bupivacaine HCl) Injection, USP Due To The Presence Of Particulate Matter Characterized As Glass 4/26/2016
Good News for NeuroDerm (NDRM) as the FDA Removes Import Alert of Infusion Pumps Used in ND0612 Clinical Trials 4/22/2016
Pharmakon Pharmaceuticals Issues Voluntary Nationwide Recall Of All Sterile Compounded Products Due To FDA Concern Of Lack Of Sterility Assurance 4/20/2016
How Olympus (OCPNF)' Superbug Problem Just Got Worse 4/19/2016
German Authorities Accuse India's Alkem Laboratories of Fudging Data in Clinical Trials 4/18/2016
Minnesota Senator Pushes FDA, Medtronic (MDT) for Infuse Study Details 4/13/2016
How Medtronic (MDT) Misplaced 1,000 Negative Infuse Reports 4/12/2016
Boston Scientific (BSX) Issues Voluntary Recall of Fetch 2 Aspiration Catheter 4/11/2016
Vascular Solutions (VASC) Recalls Guardian II Hemostasis Valves 4/11/2016
Medtronic (MDT) Disputes Star Tribune's Infuse Story 4/11/2016
Boston Scientific (BSX)'s Watchman FLX Pulled From European Shelves Over Embolism Concerns 4/5/2016
Federal Report Reveals Theranos Devices Often Failed Accuracy Requirements 4/4/2016
FDA Probes Allegations of Counterfeit Boston Scientific (BSX) Mesh 4/4/2016
1,000+ Women are Suing Johnson & Johnson (JNJ) for Allegedly Covering Up Baby Powder Cancer Risk for Decades 4/1/2016
FDA Hits Cook Medical's Central Venous Cath Recall with a Class 1 Tag 3/31/2016
FDA Warns DNA4Life, DNA-CardioCheck and Interleukin Genetics (ILGN) for DTC Genetic Tests 3/29/2016
Health Canada Release: Information Update - Jamp-Hydrocortisone Cream 1% Recalled Due To Contamination With Bacteria, Yeast And Mould 3/25/2016
FDA Slaps Terumo with Warning Letter Over Destination Guiding Vascular Sheaths 3/25/2016
FDA Announces Enhanced Warnings For Immediate-Release Opioid Pain Medications Related To Risks Of Misuse, Abuse, Addiction, Overdose And Death 3/23/2016
$90 Million China Vaccine Scandal Prompts Angry Backlash From Parents And Doctors 3/22/2016
FDA Slaps a Class I Recall on Verathon's Video Laryngoscope 3/21/2016
Physio-Control Recalls Certain Lots of Its AED Electrodes 3/18/2016
FDA Warns India's Emcure Pharma for Repeatedly Fudging Data at Plant 3/17/2016
Abbott (ABT) Voluntarily Recalls MitraClip System 3/16/2016
Gilead (GILD)'s Zydelig Under Review in Europe Following Reported Deaths, Side Effects When Combined With Other Drugs 3/15/2016
Pfizer (PFE), Abbott (ABT) to Stop Selling Cough Syrups After India Ban 3/15/2016
Government Scientists Raise Questions About the Potential Risks of Abbott (ABT)'s Dissolving Stent 3/15/2016
Teleflex Incorporated (TFX) Recalls ARROW International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits 3/11/2016
Teva (TEVA) Initiates Voluntary Nationwide Recall Of One Lot Of Amikacin Sulfate Injection USP 1 Gram/4ml (250 Mg/Ml) Vials Due To Glass Particulate Matter 3/10/2016
Maharashtra FDA to Test Johnson & Johnson (JNJ) Baby Powder for Cancer-Causing Substances After $75 Million U.S Verdict 3/10/2016
FDA Warns Repro-Med Systems (REPR) on Freedom Infusion Set Issues 3/10/2016
Report Questions if Theranos Provided Blood Tests to 81 Patients Despite Quality Assurance Issues 3/8/2016
FDA Expands Draeger's Ventillator Recall to Include Power Supply Batteries 3/4/2016
How Olympus (OCPNF)' Scope Problems Got So Unbelievably Bad 3/3/2016
FDA Slaps ReWalk (RWLK) with Warning Letter for Failure to Submit Post-Market Surveillance Report for Exoskeleton 3/3/2016
FDA Wants Bayer (BAY) to Do More Studies on Essure Birth Control Device 3/1/2016
Hospital Warns 213 Patients May Have Been Exposed To Hepatitis, HIV Due To Tampering of Drugs By Ex-Employee 2/26/2016
Abbott (ABT) Warns Surgeons on Potential Issue with Mitraclip Heart Implant 2/26/2016
Cook Medical Expanded Its Class I Recall for Beacon Tip Angiographic Catheters 2/26/2016
More Bad News for Theranos as Rice University Study Questions the Accuracy of Fingerprick Blood Testing 2/25/2016
Consumers are Uneasy Using Johnson & Johnson (JNJ) Products After Firm is Ordered to Pay $75 Million for Talc Powder Cancer Case 2/25/2016
UK Firm Bedfont Scientific Banned from Shipping Medical Devices to U.S. 2/24/2016
Sure Genomics Gets FDA Letter for Marketing Diagnostic Without Approval 2/19/2016
303 Fetal Deaths May be Linked to Bayer HealthCare (BAY)'s Essure; Congressman Raises New Concerns About Contraceptive Device 2/18/2016
Zimmer (ZMH) Biomet Warns of Packaging Issue with Hip, Knee and Shoulder Implants 2/18/2016
Theranos Files Plans with U.S. Regulators to Fix All Serious Deficiencies at Bay Area Lab 2/16/2016
Pfizer (PFE) Recalls Advil Liquid Products for Children and Infants 2/16/2016
Ex-FDAAdvisoryCommittee.com Head Accused of Conspiring to Suppress Information About Harmful Effects of Johnson & Johnson (JNJ) Antibiotic 2/11/2016
Cook Medical Issues Global Recall of Select Lots of Central Venous Catheters and Pressure Monitoring Sets and Trays 2/11/2016
Dräger Slapped With Another Class I Recall 2/9/2016
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
FDA Discovers Wockhardt (WOCKHARDT.BO) Hid Failed Tests and Deleted Data at Indian Plant 2/1/2016
Aurobindo Pharma (AUROBINDOP.BO) Shares Fall On FDA Concerns 2/1/2016
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
Pfizer (PFE) Quietly Recalls Three Lots of Blockbuster Drug Lyrica 1/25/2016
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
Off Label Use of Roche (RHHBY)’s Avastin in India Puts 15 in the Hospital, Prompts Officials to Halt Using the Drug 1/21/2016
Man in Coma Dies After Bial's Botched Drug Trial in France, Five Remain Hospitalized 1/19/2016
FDA Slaps BrainLAB AG's Cranial IGS System with a Class I Recall 1/18/2016
Former C.R. Bard Employee Says 510(k) Process May Be to Blame for Vena Cava Filter Deaths 1/14/2016
Overdose Fears Spark Recall Of Children's Cough Syrup 1/13/2016
Ex-GlaxoSmithKline (GSK) Biostatistician Sues, Claims He was Let Go Over Nicoderm Studies 1/13/2016
FDA Tags Stryker's Pleural Drainage Device Recall a Class I 1/13/2016
Why Merck & Co. (MRK) May Find Twitter an Unfriendly Environment to Be In 1/11/2016
Regeneron (REGN) Investors Get Jitters From False Praluent Data 1/8/2016
PA Rep Wants the FDA to Launch Criminal Probe into Morcellator Deaths 1/7/2016
Cadila Healthcare Shares Plunge After FDA Warning 12/31/2015
Boston Scientific (BSX) Recalls Chariot Guiding Sheaths After Pieces Broke Off in Patients 12/10/2015
Defective Device Forces Regulators to Take a Hard Look at Bayer (BAY)'s Xarelto Trial 12/9/2015
Chinese Customs Officers Seize 120,000 Fake Face Masks Supposedly Made By 3M Company (MMM) 12/9/2015
Olympus (OCPNF) Recalls Select EndoEye HD II Endoscopes Over Heat Issue 12/9/2015
FDA Report Says Pfizer (PFE) Chinese Plant Hid Failures, Used Expired Ingredients 12/8/2015
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
Boston Scientific (BSX)'s Artery-Clearing Tools Recalled After Patient Death 11/30/2015



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