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Medical Dev. & Diag. - Recalls and Warnings
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
Abbott (ABT) Warns on Topera Catheter Spline Fracture Risk 5/24/2016
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
Failure To Report Infuse Data Was Unintentional, Says Medtronic (MDT) 5/19/2016
Top Reasons FDA Issued Device Makers 483's And Warning Letters In 2015 5/19/2016
FDA Lifts Recall On Custom Ultrasonics' Endoscope Reprocessors 5/17/2016
Why B.Braun Medical's Latest Recall is a Serious One 5/6/2016
Cook Medical Recalls Catheters with Beacon Tip Technology 5/4/2016
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
Federal Health Regulators Release Lightly Redacted Theranos Report with More Details 5/2/2016
Study Reveals More Than One-Third of Hip Implants Made by Johnson & Johnson (JNJ)'s DePuy Synthes Were the Wrong Size 4/29/2016
Good News for NeuroDerm (NDRM) as the FDA Removes Import Alert of Infusion Pumps Used in ND0612 Clinical Trials 4/22/2016
A Look Behind The Star Tribune's Special Report On Medtronic (MDT), "A Question Of Risk" 4/22/2016
Medtronic (MDT) to Recall Battery Packs Used in Medical Devices 4/20/2016
How Olympus (OCPNF)' Superbug Problem Just Got Worse 4/19/2016
The 10 Most Serious Medtech Recalls Of Early 2016 4/15/2016
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
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
B.Braun Medical Issues Voluntary Nationwide Recall Of Lot J5J706, 5% Dextrose Injection USP In PAB(R) Container Due To Leakage And/Or Particulate Matter Identified To Be Microbial Growth 3/29/2016
FDA Slaps Terumo with Warning Letter Over Destination Guiding Vascular Sheaths 3/25/2016
FDA Proposes Ban On Most Powdered Medical Gloves 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
Abbott (ABT) Voluntarily Recalls MitraClip System 3/16/2016
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
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
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
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
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
All Sientra (SIEN) Medical Devices to Return to U.S. in March 2/8/2016
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
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