Category Archives: Food & Drug Recalls

FDA approves first gel for sealing corneal incision after cataract surgery

The U.S. Food and Drug Administration today approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to today’s approval, stitches were the only option for closing a leaking corneal incision after cataract surgery.

Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance and TRUEtrack Blood Glucose Meters

Nipro Diagnostics, Inc. today announced it is initiating a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed both in the United States and outside the United States. The company has determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters distributed in the United States have an incorrect factory-set unit of measure that displays the glucose result in mmoi/L rather than mg/dl.

Tonia’s Biscotti II LLC Issues Allergy Alert on Undeclared Wheat, Milk, and Soy in Tonia’s Biscotti Sampler Bags, Lemon Biscotti Dipped in White Chocolate Bags, and Individually Wrapped Biscotti of All Flavors

Tonia’s Biscotti II LLC of Homer, AK is recalling Sampler Bags, Lemon Biscotti dipped in White Chocolate Bags, and individually wrapped biscotti of all flavors because they may contain undeclared wheat, milk, and soy. People who have an allergy or severe sensitivity to wheat, milk, and/or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Voluntary Field Corrective Action Initiated for Vital Signs Device’s CO2 Multi Absorber Due to a Health Risk

Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. The Multi Absorber Original may have a thin wall condition which may lead to small holes in the water (drain tube). This may result in a loss of anesthetic gases, ventilation and oxygenation.