St. Jude Medical (STJ)'s Durata Defibrillator "Immune" to Riata Flaws?
6/19/2013
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Fresenius Medical Care Receives FDA Warning Letter
6/19/2013
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Endologix Inc. AFX Introducer System: Class 1 Recall - Reports of Dilator Breaking During Procedures
6/18/2013
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FDA Urges Protection of Medical Devices From Cyber Threats
6/14/2013
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Cook Medical: Trouble Ahead Following Zilver PTX Stent Recall
6/12/2013
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Labeling Issues Plague Boston Scientific Corporation (BSX)'s Balloon Dilators
6/11/2013
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Intuitive Surgical, Inc. (ISRG) Ships New Surgical Scissors Following Crack Warning
6/6/2013
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Nephron Pharmaceuticals' EZ Breathe Atomizer Tagged With Class 1 Recall
6/5/2013
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FDA Warns CooperSurgical, Inc. About Texas Manufacturing Plant
5/31/2013
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FDA Warns Edwards Lifesciences (EW) on Quality
5/30/2013
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Boston Scientific Corporation (BSX) Wants Major Changes to Recall/Enhancement Draft Guidance
5/30/2013
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Chinese Regulators Warn of Software Glitch in Philips Healthcare's Pinnacle3 Radiation Therapy Software
5/29/2013
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U.K. Regulators Warn on Unomedical's Endotracheal Tubes
5/29/2013
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FDA Gives Cook Medical's Zilver PTX Drug-Eluting Peripheral Stent a Serious Warning
5/28/2013
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Symbios Medical Products Recalls GoPump and GOBlock Kits Following Patient Complaints
5/23/2013
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FDA Pins Abbott Diabetes Care (ABT)'s FreeStyle InsuLinx Blood Glucose Meters With Class 1
5/20/2013
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Roche (RHHBY) Recalls CoaguChek Monitors
5/20/2013
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Johnson & Johnson (JNJ) to Discontinue Metal-on-Metal Hip Products
5/17/2013
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FDA Warns Hospira, Inc. (HSP) -- Again
5/16/2013
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Maquet Cardiovascular LLC's Class I Ventilator Battery Recall Affects 90k Units
5/16/2013
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Australia Recalls a Johnson & Johnson (JNJ) Device
5/14/2013
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Intuitive Surgical, Inc. (ISRG) Warns on Da Vinci Scissor Crack Risk
5/13/2013
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FDA Warns Covidien (COV)'s Stolen Stapler Reloads Up for Sale Before Sterilization
5/8/2013
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Cardinal Health, Inc. (CAH) Recalls Pre-Assembled Filter and Anesthesia Circuit in Packs
5/7/2013
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Medtronic, Inc. (MDT) Warns on Wire Damage Risk With Deep-Brain Stimulation Implants
5/3/2013
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Cook Medical Initiates Global Recall of Its Zilver® PTX®Drug Eluting Stent
4/25/2013
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GE Healthcare Warns on Certain Giraffe Infant Care Systems
4/24/2013
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Covidien plc (COV) Recalls Power Pac Batteries for Newport™ HT70 and HT70 Plus Ventilators
4/19/2013
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FDA Cites Baxter Healthcare Corporation (BAX) for Selling Pump Without PMA
4/17/2013
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Abbott Laboratories (ABT) Recalls FreeStyle InsuLinx Glucose Meters
4/15/2013
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Integra LifeSciences Corporation (IART) Recalls Some Collagen Items
4/12/2013
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HeartWare (HTWR) Device Malfunction Led to Death, FDA Reports
4/11/2013
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Recall: Hoya Surgical Optics, Inc. Pulls Intraocular Lenses
4/11/2013
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CareFusion Corporation Hit by Another Warning for Its Alaris Infusion Pump
4/9/2013
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A Real False Alarm: Johnson & Johnson (JNJ) Recalls Another Product
4/8/2013
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Spacelabs Healthcare Pulls Anesthesia Workstations Over Excess CO2 Risk
3/28/2013
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Stereotaxis, Inc. (STXS) Receives Delisting Warning From Nasdaq
3/26/2013
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Asia Recalls Merck Sharp & Dohme (MRK)'s Contraceptive Devices
3/26/2013
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LifeScan, Inc.'s OneTouch Verio IQ Blood-Glucose Meters Recalled
3/25/2013
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NuVasive, Inc. (NUVA) Ticketed With FDA Warning Letter
3/20/2013
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Symbios Medical Products' PumpKit Slapped With Recall
3/19/2013
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Vascular Solutions (VASC) Issues Recall on Guardian® II and Guardian II NC Hemostasis Valves Due to Risk of Air Embolism
3/19/2013
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Fresenius Medical Care AG & Co. KGaA (FMS) Reveals FDA Warning Letter
3/15/2013
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Johnson & Johnson (JNJ) Exec Says Hip Implant Was Recalled for Clinical Reasons
3/14/2013
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FDA Warns Stryker on Quality Issues, Marketing Practices
3/12/2013
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Honey, Pass the… Uh-Oh, Johnson & Johnson (JNJ) Recalls K-Y Jelly
3/8/2013
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FDA Issues Warning Letter to Medtronic, Inc. (MDT) CoreValve Investigator
2/28/2013
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FDA Slaps Lumenis Ltd. (LUME) Recall With Class I Status
2/26/2013
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Johnson & Johnson (JNJ) Recalls Knee Replacement Device
2/25/2013
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FDA Sends Warning Letter to Atossa Genetics, Inc. (ATOS)
2/25/2013
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FDA Cites Alcon, Inc. (ACL) for Improperly Marketing Laser
2/22/2013
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Johnson & Johnson (JNJ)'s Toxicologist Says Metal From Recalled Hip Harmless
2/22/2013
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DePuy Orthopaedics, Inc. (JNJ) Knew of Problems Well Before Recall
2/19/2013
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FDA Sends Warning Letter to Rigid FX Orthopedics for the Clearview Wrist Fixation System
2/15/2013
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FDA Lays Down 2 Warning Letters for Bacterin International, Inc.
2/15/2013
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Johnson & Johnson (JNJ) Warns of Safety Risk for 7,500 Non-U.S. Hip Implants
2/15/2013
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Hospira, Inc. (HSP) Gets FDA Notice Over Medical Device Problems
2/14/2013
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FDA Slaps Highest Risk Label on St. Jude Medical (STJ)'s Amplatzer TorqVue FX Recall
2/13/2013
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HeartWare (HTWR) Warns of Heart Device Defect
2/11/2013
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Hamilton Medical, Inc. Recalls Ventilators Over Software Glitch
2/7/2013
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GE Healthcare Announces Class I Recall of Infant Resuscitation Kits
2/4/2013
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Vycor Medical Inc. Recalls Brain Access System Over Potential Contamination
1/31/2013
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ICU Medical, Inc. (ICUI) to Discontinue CLC2000 Devices
1/28/2013
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FDA Smacks Bausch & Lomb With a Recall
1/24/2013
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Analysts Say St. Jude Medical (STJ) May Face New Recall
1/17/2013
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Recall of Selected Lots of 2 Brands of ACUVUE Contact Lenses
1/16/2013
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FDA Releases St. Jude Medical (STJ) Warning Letter
1/16/2013
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Use of New Boston Scientific Corporation (BSX) Device Should be Limited: Doctor
1/3/2013
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Fire Risk Leads Praxair, Inc. (PX) to Recall Grab 'n Go Oxygen Tanks
1/3/2013
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FDA Recalls 2 Ventilator Models From Ventlab
1/2/2013
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FDA Sends Warning Letter to Mindray Medical Over Manufacturing Problems
1/2/2013
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GE Healthcare Recalls Resuscitator Components
1/1/2013
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Fake Allergan Inc. (AGN) Botox Warning by FDA to 350 Medical Practices
12/27/2012
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Bunnell Incorporated Ventilator Products Recalled
12/27/2012
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Medtronic, Inc. (MDT) Recall Gets Class I Status From FDA
12/27/2012
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FDA Warns on Improper Lasik Ads
12/20/2012
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Zimmer Spine, Inc. Issues Worldwide Recall of all 315 Units of the PEEK Ardis® Inserter
12/20/2012
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Recalls: Haemonetics Corporation (HAE) Warns on Potential Leaks
12/18/2012
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Ethicon, Inc. (JNJ) Class I Recall - Potential for Packaging Breach
12/14/2012
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Natus Medical Incorporated (BABY) Cooling Cap Hit With FDA Class I Recall
12/13/2012
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Radiation Danger Alert for Handheld Dental X-Ray Machines From Zhengzhou Tianjie Electronic Equipment Co.
12/4/2012
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Verathon Inc. Recalls GlideScope GVL Video Laryngoscopes
11/30/2012
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Bracco Diagnostics Inc. Recalls Isovue PFS Injector Syringes
11/28/2012
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Report Raises Concerns Over St. Jude Medical (STJ) Heart Device
11/21/2012
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Another Warning for CareFusion Corporation's Alaris Infusion Pumps
11/16/2012
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Mindray Medical has Initiated a Voluntary Recall of A3/A5 Anesthesia Delivery System
11/14/2012
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Integra LifeSciences Corporation (IART)'s UK Facility Gets FDA Warning Letter
11/13/2012
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Baxter Healthcare Corporation (BAX) Issues Class 1 Recall on Buretrol Solution Sets
11/9/2012
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Feds Closed Probe Into Edwards Lifesciences Corporation (EW)'s Recalled Vigilance Heart Monitor
11/8/2012
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AMS Recalls Its AdVance Male Sling System
11/6/2012
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FDA Warns Light Therapy Maker, Avalon Effect Inc., for Fungal Meningitis Treatment Claims
11/6/2012
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Johnson & Johnson (JNJ) Recalls Surgical Stapler Devices Over Serious Safety Issue
10/29/2012
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FDA Smacks Johnson & Johnson (JNJ) With Class I Recall Over Symbiq Infusion System
10/29/2012
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St. Jude Medical (STJ) Receives FDA Warning Letter About One of Its Facilities
10/25/2012
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FDA Labels Accutron Recall Class I Over Nitrous Oxide Leak That May Harm Patients
10/17/2012
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Accutron, Inc. Issues Nationwide Voluntary Recall of Flowmeters
10/9/2012
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FDA Warns Against Use of Stryker Corporation (SYK) Surgical Suction Systems Due to Report of a Death
10/8/2012
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MS Patients Seek Therapy Despite FDA Warning
10/8/2012
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FDA Warns Zimmer (ZMH) Over Manufacturing of Hip Devices
10/2/2012
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Stryker Corporation (SYK) Recalls Neptune Devices After Death Reported
9/26/2012
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Stryker Orthopaedics Recalls Rejuvenate Modular Hip Systems
9/26/2012
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Philips Healthcare's Respironics, Inc. (RESP) Issues Another Ventilator Recall
9/4/2012
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I-Flow Corporation (IFLO) Recalls ON-Q Pump With ONDEMAND Bolus Button
9/4/2012
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Baxter Healthcare Corporation (BAX) Recalls Automix Nutrition Compounder Systems
8/30/2012
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FDA Warns Hospira, Inc. (HSP) Over Costa Rica Infusion Device Plant
8/29/2012
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FDA Asks Johnson & Johnson (JNJ)'s DePuy Orthopaedics, Inc. (JNJ) to Recall Unused Custom Implants
8/27/2012
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FDA Recalls Another CareFusion Corporation Infusion Pump
8/23/2012
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Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa
8/22/2012
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Medtronic, Inc. (MDT)’s Drug Pump Failure Prompts FDA Meeting Request
8/22/2012
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Johnson & Johnson (JNJ) Unit Recalls Bone Putty
8/22/2012
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Covidien plc (COV) Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits That Contain DGPHP RFA High-Power Single Use Grounding Pads
8/20/2012
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Johnson & Johnson (JNJ) Recall: Ethicon Endo-Surgery, Inc. Pulls Surgical Staplers
8/13/2012
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FDA Issues Warning for Fake Medical Equipment
8/7/2012
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B. Braun Medical Ltd. Infusion System Part of Class I Recall
8/3/2012
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FDA Classifies Recall of a Component of CareFusion Corporation's Alaris Infusion Pump as Class I
8/2/2012
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DUKAL Corporation Antiseptic Wipes Made in China Pulled in U.S.
8/2/2012
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St. Jude Medical (STJ) Recalls Eon, Eon Mini Pain Management Implants on Battery, Charging Issues
8/1/2012
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Arrow International, Inc. (ARRO) Multi-Lumen Venous Catheterization Set With Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient
7/31/2012
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Johnson & Johnson (JNJ) Recalls Some Duragesic Pain Patches
7/20/2012
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Respironics, Inc. (RESP) Issues Voluntary Recall of a Limited Number of Trilogy Ventilators
7/18/2012
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CareFusion Corporation Provides Update on Voluntary Recall of EnVe® Ventilator
7/18/2012
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Alere Inc. (ALR) Recalls 897,000 Heart Attack, Drug Test Kits
7/12/2012
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GE Healthcare Recalls Some Ventilators on Safety Issue
7/12/2012
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Stryker Recalls Certain Hip Implant Products
7/9/2012
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China Regulators Warn on Pace Medical Corporation's Micro-Pace Pacemakers
7/9/2012
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MAQUET Initiates Class I Recall of the FLOW-i Anesthesia System
7/6/2012
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CareFusion Corporation Recalls Infant Breathing Product
7/3/2012
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U.K.'s Medicines & Healthcare Products Regulatory Agency Warns on Reusable Probes Following Patient Death
6/29/2012
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FDA Warns Covidien plc (COV) Over Surgical-staple Deaths
6/28/2012
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FDA Probing Safety of Metal-on-Metal Hip Implants
6/27/2012
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St. Jude Medical (STJ)'s Riata Leads Recalled Because of the Potential Risk of Serious Injury or Patient Death if the Device Malfunctions
6/22/2012
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FDA Issues a Class 1 Recall on Nidek Medical Products, Inc.'s Oxygen Concentrators
6/20/2012
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Fresenius Medical Care's Failure to Warn of Product Risk Draws Inquiry
6/15/2012
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Ethicon Endo-Surgery, Inc. Warns on Counterfeit Surgical Clips on the U.S. Market
6/14/2012
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St. Jude Medical (STJ) Shares Drop on Report of Heart Lead Problem
6/13/2012
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Johnson & Johnson (JNJ)'s Cordis Corporation (JNJ) Unit Recalls Catheters
6/13/2012
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Siemens Healthcare Diagnostics Gets Warning Letter Over Blood Sample Testing Device
6/7/2012
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Johnson & Johnson (JNJ) to Halt Sales of Vaginal Mesh Implants
6/5/2012
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Smith & Nephew Inc. (SNN) Withdraws Hip Device Component
6/4/2012
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FDA Issues Class I Recall on Other-Sonic Ultrasound Gel
6/1/2012
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FDA Warns Johnson & Johnson (JNJ) Over Vaginal Products
5/31/2012
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BC Cancer Agency Recalls Cervical Cancer Treatment Device
5/29/2012
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FDA Panel Wants a Closer Look at St. Jude Medical (STJ) Heart Implant
5/29/2012
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Moog Medical Devices Group Recalls IV Sets for Reverse Fluid Flow
5/25/2012
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Alere Inc. (ALR) Recalls 803,000 Tests for Heart Attacks
5/24/2012
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Covidien plc (COV) Recalls Roticulator Staplers
5/21/2012
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|
Medical Device Alert on TaiDoc's Blood Glucose Monitoring System
5/18/2012
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Department of Homeland Security Issues Warning on Medical Device Threats
5/17/2012
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Vascular Expert Supports FDA Warning About Experimental Therapy for MS Patients
5/14/2012
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SEC Probes Baxter International, Inc. (BAX) on Infusion Pump Recalls
5/8/2012
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Roche Diagnostics Corporation (ROG.VX) Recalls Two Troponin I Assays
4/25/2012
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FDA Cites Orthopedic Medical Device Company Extremity Medical Over Violations
4/25/2012
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FDA Issues Warning Over Fentanyl Patches; Makers Include Mylan Inc. (MYL) and Watson Pharmaceuticals, Inc. (WPI)
4/23/2012
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US Marshals Seize Pharmaceutical Innovations' Contaminated Ultrasound Gel That Allegedly Sickened 16 Patients
4/20/2012
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More Recalls/Warnings on Johnson & Johnson (JNJ)'s Metal-on-metal Hip Implants in Australia, U.K, New Zealand
4/16/2012
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Thoratec Corporation (THOR)'s Heartmate II Pump Recalled
4/6/2012
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|
Oxygen Therapy Device for Wound Healing from Ogenix Corporation Gets FDA Warning Letter
4/5/2012
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St. Jude Medical (STJ) Yanks Brio Deep Brain Stimulator After 11 Malfunctions
3/30/2012
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|
Two Medical Device Companies, Orthopedic Alliance and Spinal Solutions, Receive FDA Warnings
3/29/2012
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Lucero Medical's Spinal Fusion Device Draws FDA Warning Letter
3/29/2012
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Smiths Medical, Inc. Issues a Market Withdrawal for CoZmonitor Blood Glucose Monitoring Systems
3/29/2012
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St. Jude Medical (STJ)'s Frayed Heart Wires May Have More Risky Defects
3/26/2012
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Medtronic, Inc. (MDT)'s EnTrust Gets U.K. Safety Alert for Battery Life
3/19/2012
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Acclarent, Inc. Recalls Inspira AIR Balloon Dilation System
3/14/2012
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Life Recovery Systems Receives Warning Letter Over Surgery Prep Device
3/14/2012
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DH Recalls Eumed Biotechnology Co. Ltd.'s EUKARE Blood Glucose Test Strip
3/5/2012
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Johnson & Johnson (JNJ) Sold FDA Rejected Hip Implants Abroad
2/15/2012
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St. Jude Medical (STJ) Device Exposes Safety Monitoring Failures, Doctor Says
2/15/2012
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Hitachi Medical Corporation's Analyzer Recalled Due to False Results
2/10/2012
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Merit Medical Systems, Inc. (MMSI) Receives FDA Warning Letter Regarding Merit Laureate(R) Hydrophilic Guidewire
2/8/2012
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Medicines and Healthcare Products Regulatory Agency Issues Alert for Coloplast's Catheter Valve
2/2/2012
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Health Warning Over DePuy Orthopaedics, Inc. (JNJ)'s Hip Implants
1/31/2012
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|
Covidien (COV) Unveils Expanded Recall of Brain Sensors
1/20/2012
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FDA Warns Johnson & Johnson (JNJ)'s DePuy Orthopaedics, Inc. (JNJ) Unit on Custom Devices
1/19/2012
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FDA Warns Thoratec Corporation (THOR) on Late Filings
1/19/2012
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Covidien (COV) Says Device Linked to Three Deaths in Thoracic Surgery
1/17/2012
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Respironics, Inc. (RESP) Completes Voluntary Recall Notification of a Limited Number of Trilogy 100 Ventilators
1/16/2012
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Ikaria Inc. Recalls Drug Delivery System
1/9/2012
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Health Equipment Maker Midmark Gets FDA Warning Letter on Sterilizers
1/5/2012
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|
FDA Targets Risks From Reused Medical Devices
12/29/2011
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Smiths Medical, Inc. Issues Urgent Device Recall of Certain Bivona® Neonatal, Pediatric, and FlexTend Tracheostomy Tubes
12/28/2011
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China's Department of Health Issues Device Alert for Medtronic, Inc. (MDT)'s Cannulae
12/21/2011
More...
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French Women "Must Have Faulty Breast Implants Removed"
12/20/2011
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Neti Pots Linked to Brain-Eating Amoeba Deaths
12/20/2011
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St. Jude Medical (STJ) Hit With Class 1 Recall of Heart Device Leads
12/16/2011
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Medicines and Healthcare Products Regulatory Agency Issues Device Alert for Hospira, Inc. (HSP)'s Respiration Monitor
12/15/2011
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|
FDA Issues Warning Letters for Misleading Advertising of Allergan Inc. (AGN)'s Lap-Band
12/14/2011
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|
China's Department of Health Issues Device Alert for Smiths Medical, Inc.'s Respiration Monitor
12/14/2011
More...
|
St. Jude Medical (STJ) Letter Warns Doctors on Defibrillator Lead Failures
12/5/2011
More...
|
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for GE Healthcare's Gas Outlet
12/2/2011
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|
FDA Investigates Stent "Shrinkage" in Boston Scientific Corporation (BSX)'s Ion, Promus Stents
11/21/2011
More...
|
Health Canada Issues Device Recall for Sorin Group Canada, Inc.'s Defibrillation Leads
11/17/2011
More...
|
CooperVision Inc. Announces Expanded Recall of Avaira Line of Contact Lenses
11/16/2011
More...
|
FDA Issues Recall for Mizuho Orthopedic Systems’ Modular Tables
11/15/2011
More...
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Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Drive Medical's Bath Lift
11/10/2011
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Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Microgen Bioproducts' Syphilis Tests
11/9/2011
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CareFusion Corporation EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation
11/7/2011
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|
Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Drive Medical's Rollator
11/7/2011
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|
FDA Warns Aesculap for Reporting, Procedural Failures
11/4/2011
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Medicines and Healthcare Products Regulatory Agency Issues Medical Device Alert for Lifecare Hospital Supplies Ltd.'s Jet Adaptors
11/4/2011
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