Aug-08-2014       Enhancement Medical; LLC          Enhancement Medical expression – Enhancement Medical expression.  model # EXP-150.  Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage:  Expression is labelled as an Intranasal Splint; intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However; Expression is currently being used off-label as a subcutaneously injected dermal filler.      Manufacturer made a change in the production process that resulted in a change in final gel weight.   RECALL EXPANDED 7/8/2014   Firm expanded their recall to include all lots of product. Aug-14-2014       Cardiovascular Systems; Inc.       Diamondback 360 Peripheral Orbital Atherectomy System. – CSI Cardiovascular Systems; Inc.; Diamondback 360 Peripheral Orbital Atherectomy System; Model Number DBP-125MICRO145; Part Number 7-10003.The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal athe...