Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
1/14/2017 5:00:00 AM
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
1/13/2017 4:00:00 PM
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
1/12/2017 2:00:00 PM
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
1/11/2017 10:30:00 PM
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
1/11/2017 3:50:00 PM
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.
1/9/2017 5:00:00 AM
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.
12/23/2016 2:35:00 PM
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
12/20/2016 3:00:00 PM
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
12/16/2016 5:01:00 PM
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.
12/14/2016 5:01:00 PM
FDA approved label updates to describe additional studies reviewed.
12/12/2016 8:05:00 PM
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.
12/9/2016 8:30:00 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.
12/1/2016 1:40:00 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.
12/1/2016 1:15:00 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.
11/26/2016 3:00:00 PM
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
11/25/2016 5:00:00 AM
Can lead to serious adverse health consequences including embolism, stroke, or death.
11/22/2016 7:50:00 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.
11/21/2016 8:00:00 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
11/21/2016 5:30:00 PM
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
11/18/2016 7:00:00 PM
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
11/15/2016 5:10:00 PM
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
11/8/2016 8:50:00 PM
Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
11/8/2016 2:15:00 PM
Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.
10/28/2016 6:45:00 PM
The most recent post-approval study results assessing post-market performance is available.
10/26/2016 3:00:00 PM