FDA MedWatch

Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized.

The recall of 12/2009 has been expanded to include four additional lots. Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.

Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.

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.

UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010

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.

Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.

Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).

FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.

Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.

FDA requires risk management plan and class-labeling changes for all LABAs.

Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.