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FDA MedWatch Safety Alerts



Last Build Date: Tue, 17 Jan 2017 10:00:00 -0500

 



ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions

Tue, 17 Jan 2017 10:00:00 -0500

Updated recommendations to help prevent the spread of infection associated with the use of these devices.



Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

Sat, 14 Jan 2017 00:00:00 -0500

Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017



Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use

Fri, 13 Jan 2017 11:00:00 -0500

Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.



PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer

Thu, 12 Jan 2017 09:00:00 -0500

Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.



Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall - Particulates Generated in Vial

Wed, 11 Jan 2017 17:30:00 -0500

The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.



Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions

Wed, 11 Jan 2017 10:50:00 -0500

Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.



Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified

Mon, 09 Jan 2017 00:00:00 -0500

These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.



ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions

Fri, 23 Dec 2016 09:35:00 -0500

IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.



Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization

Tue, 20 Dec 2016 10:00:00 -0500

Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.



Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised

Fri, 16 Dec 2016 12:01:00 -0500

FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.



General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women

Wed, 14 Dec 2016 12:01:00 -0500

Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain.



Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

Mon, 12 Dec 2016 15:05:00 -0500

FDA approved label updates to describe additional studies reviewed.



Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate

Fri, 09 Dec 2016 15:30:00 -0500

Excess material may separate from catheter during use and enter patient’s bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.



Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients

Thu, 01 Dec 2016 08:40:00 -0500

Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.



Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient

Thu, 01 Dec 2016 08:15:00 -0500

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.



DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk

Sat, 26 Nov 2016 10:00:00 -0500

DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.



Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids

Fri, 25 Nov 2016 00:00:00 -0500

The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.



FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation

Tue, 22 Nov 2016 14:50:00 -0500

Can lead to serious adverse health consequences including embolism, stroke, or death.



Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance

Mon, 21 Nov 2016 15:00:00 -0500

Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.



Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

Mon, 21 Nov 2016 12:30:00 -0500

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.