Last Build Date: Thu, 16 Feb 2017 09:30:00 -0500
Thu, 16 Feb 2017 09:30:00 -0500Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Wed, 15 Feb 2017 08:30:00 -0500Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Thu, 09 Feb 2017 11:00:00 -0500Faulty 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.
Thu, 09 Feb 2017 09:35:00 -0500Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
Thu, 09 Feb 2017 07:45:00 -0500Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Thu, 02 Feb 2017 13:24:00 -0500Reactions 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.
Mon, 30 Jan 2017 14:10:00 -0500The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Fri, 27 Jan 2017 13:55:00 -0500Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
Fri, 27 Jan 2017 13:15:00 -0500Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.
Wed, 25 Jan 2017 08:00:00 -0500Injected 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.
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.