FDA MedWatch

Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.

Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.

Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.

Device computer may shut down without an alarm, which can lead to serious injuries or death.

Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.

Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.