Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
2/16/2017 2:30:00 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
2/15/2017 1:30:00 PM
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.
2/9/2017 4:00:00 PM
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
2/9/2017 2:35:00 PM
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
2/9/2017 12:45:00 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.
2/2/2017 6:24:00 PM
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
1/30/2017 7:10:00 PM
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
1/27/2017 6:55:00 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.
1/27/2017 6:15:00 PM
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.
1/25/2017 1:00:00 PM
Updated recommendations to help prevent the spread of infection associated with the use of these devices.
1/17/2017 3:00:00 PM
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