St. Jude Medical sent a letter to doctors in November advising that several hundred of its Optisure dual-coil defibrillator leads may not work because of damaged insulation on the leads. The insulation on the leads may have been damaged during the manufacturing process. The Optisure lead recall was then announced by the FDA and classified as a Class 1 Advisory. A Class 1 recall means the FDA believes using one of the devices could result in serious health consequences.… Read More


Fresenius Medical Care North America(FMCNA), a Massachusetts based company, will voluntarily recall 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). The products were recalled because they could develop harmful levels of bacteria during their shelf life. The bacteria in the solution has been identified as Halomonas (species 1, 2, 3), a Gram Negative bacteria.… Read More


The FDA and DePuy have issued a class-1 recall, the highest alert, of DePuy’s femur and tibia implant called the LPS Lower Extremity Dovetail Intercalary Component. This is because this device has the potential to fracture when the patient walks normally or conducts normal activities – like ascending stairs, or rising from a chair. People weighing over 200 pounds or with high activity levels are at higher risk of fractures.… Read More