Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant [...]

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as [...]

11 percent possibility of failure after 3 years.
FOR IMMEDIATE RELEASE — PLEASANTON, CA — October 24, 2008—Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical [...]

The U.S. Consumer Product Safety Commission announced a recall June 10 of 28,000 sets of camouflage child pajamas sold at The Children’s Place retail stores and website between December 2006 and January 2008 for $15 to $17. The screen print on the shirt contains excess levels of lead.
This recall involves long- and short-sleeved pajama sets. [...]

The U.S. Consumer Product Safety Commission today announced a voluntary recall of Infant and Toddler Shortalls made by Sara Lynn Togs, because the buttons on the shoulder straps can detach, posing a choking hazard to young children
The recall involves about 1800 items of Infant and Toddler Gingham and Flannel Shortalls, which are overalls with short [...]

NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/War Wash Products. T
The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these products non-sterile.
Non-sterile eye drops pose an unacceptable risk of causing eye infections, which could lead to blindness. [...]

Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function.
The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated [...]

MOM Enterprises Inc., and FDA informed consumers and healthcare providers that Baby’s Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled due to the presence of Cryptosporidium infection.
The product is labeled Baby’s Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used [...]

Bodee LLC, the maker of Zencore announced today that it is conducting a voluntary nationwide recall of all the company’s supplement product sold under the name Zencore Tabs.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related [...]

Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier.
The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in [...]