Last Build Date: Tue, 17 Jan 2017 10:00:00 -0500
Tue, 17 Jan 2017 10:00:00 -0500Updated recommendations to help prevent the spread of infection associated with the use of these devices.
Sat, 14 Jan 2017 00:00:00 -0500Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Fri, 13 Jan 2017 11:00:00 -0500Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
Thu, 12 Jan 2017 09:00:00 -0500Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Wed, 11 Jan 2017 17:30:00 -0500The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Wed, 11 Jan 2017 10:50:00 -0500Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Mon, 09 Jan 2017 00:00:00 -0500These 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.
Fri, 23 Dec 2016 09:35:00 -0500IgM 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.
Tue, 20 Dec 2016 10:00:00 -0500Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Fri, 16 Dec 2016 12:01:00 -0500FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
Wed, 14 Dec 2016 12:01:00 -0500Published 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.
Mon, 12 Dec 2016 15:05:00 -0500FDA approved label updates to describe additional studies reviewed.
Fri, 09 Dec 2016 15:30:00 -0500Excess 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.
Thu, 01 Dec 2016 08:40:00 -0500Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Thu, 01 Dec 2016 08:15:00 -0500Sibutramine 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.
Sat, 26 Nov 2016 10:00:00 -0500DMAA 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.
Fri, 25 Nov 2016 00:00:00 -0500The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Tue, 22 Nov 2016 14:50:00 -0500Can lead to serious adverse health consequences including embolism, stroke, or death.
Mon, 21 Nov 2016 15:00:00 -0500Administration 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.
Mon, 21 Nov 2016 12:30:00 -0500Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.