MedWatch Safety Alert RSS Feed
FDA MedWatch Safety Alerts
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Posted: January 14, 2017, 5:00 am
Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
Posted: January 13, 2017, 4:00 pm
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Posted: January 12, 2017, 2:00 pm
Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall - Particulates Generated in Vial
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Posted: January 11, 2017, 10:30 pm
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Posted: January 11, 2017, 3:50 pm
Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified
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.
Posted: January 9, 2017, 5:00 am
ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions
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.
Posted: December 23, 2016, 2:35 pm
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Posted: December 20, 2016, 3:00 pm
Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
Posted: December 16, 2016, 5:01 pm
General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women
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.
Posted: December 14, 2016, 5:01 pm
Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer
FDA approved label updates to describe additional studies reviewed.
Posted: December 12, 2016, 8:05 pm
Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate
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.
Posted: December 9, 2016, 8:30 pm
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Posted: December 1, 2016, 1:40 pm
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.
Posted: December 1, 2016, 1:15 pm
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.
Posted: November 26, 2016, 3:00 pm
Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Posted: November 25, 2016, 5:00 am
Can lead to serious adverse health consequences including embolism, stroke, or death.
Posted: November 22, 2016, 7:50 pm
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.
Posted: November 21, 2016, 8:00 pm
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: November 21, 2016, 5:30 pm
GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Posted: November 18, 2016, 7:00 pm