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February 24, 2017 at 8:00 PM
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
February 22, 2017 at 8:00 AM
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
February 16, 2017 at 9:30 AM
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
February 15, 2017 at 8:30 AM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
February 09, 2017 at 11:00 AM
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
February 09, 2017 at 9:35 AM
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
February 09, 2017 at 7:45 AM
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
February 02, 2017 at 1:24 PM
Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.
January 30, 2017 at 2:10 PM
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
January 27, 2017 at 1:55 PM
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
January 27, 2017 at 1:15 PM
Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.
January 25, 2017 at 8:00 AM
Injected particulate may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
January 17, 2017 at 10:00 AM
Updated recommendations to help prevent the spread of infection associated with the use of these devices.
January 14, 2017 at 12:00 AM
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
January 13, 2017 at 11:00 AM
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
January 12, 2017 at 9:00 AM
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
January 11, 2017 at 5:30 PM
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
January 11, 2017 at 10:50 AM
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
January 09, 2017 at 12:00 AM
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.
December 23, 2016 at 9:35 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.
December 20, 2016 at 10:00 AM
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
December 16, 2016 at 12:01 PM
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
December 14, 2016 at 12:01 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.
December 12, 2016 at 3:05 PM
FDA approved label updates to describe additional studies reviewed.
December 09, 2016 at 3:30 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.