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FDA MedWatch Safety Alerts
Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates
Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Posted: August 25, 2016, 4:00 pm
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Posted: August 22, 2016, 3:45 pm
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Posted: August 19, 2016, 5:00 pm
Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack
Risk of sub-therapeutic dose as well as potential microbial contamination.
Posted: August 18, 2016, 6:20 pm
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
Posted: August 17, 2016, 6:15 pm
System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Posted: August 17, 2016, 1:30 pm
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.
Posted: August 15, 2016, 9:00 pm
NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Posted: August 12, 2016, 11:20 pm
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
Posted: August 12, 2016, 6:00 pm
Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Posted: August 9, 2016, 12:00 pm
Administration to a patient may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
Posted: August 5, 2016, 5:20 pm
VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage
Risk of serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
Posted: August 5, 2016, 1:00 pm
Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter
Administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected.
Posted: August 3, 2016, 12:30 pm
Ventilator shutdown may cause serious adverse health consequences, including death.
Posted: July 28, 2016, 6:20 pm
Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
Posted: July 26, 2016, 4:01 pm
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
Posted: July 22, 2016, 6:15 pm
Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
Posted: July 22, 2016, 2:00 pm
Reports of hair loss, hair breakage, balding, itching, and rash.
Posted: July 19, 2016, 5:00 pm
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
Posted: July 16, 2016, 4:00 am
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.
Posted: July 12, 2016, 7:30 pm