FDA Seizes Ozone Generators, Unapproved for Treating Illnesses
The Food and Drug Administration has seized dozens of ozone generators made by a California company and promoted as a way to treat cancer, AIDS, hepatitis, herpes, and other diseases and conditions.
Continue →Edwards Lifesciences Recalls Aquarius Hemodialysis System
A medical device used to remove waste and excess fluids from kidney failure patients is being recalled following reports of potentially dangerous fluid imbalances in some patients, the Food and Drug Administration.
Continue →Chondrolysis: Painful Joint Injury Linked to Use of Pain Pumps
The use of pain pumps to deliver powerful painkilling narcotics directly to shoulders, knees, and other joints following surgery has been associated with a rare but very painful injury called chondrolysis. When joint cartilage dies and leaves bones to grind together, it can mean permanent and severe loss of range of motion and additional procedures to replace the damaged joint.
Continue →Millions of Infusion Set Needles Recalled
More than two million infusion set needles are included in an urgent Class I recall today because the medical devices may have design and manufacturing defects that can endanger patients.
Continue →Defective Insulin Syringes Recalled
GlucoPro Insulin Syringes made by Nipro Medical Corporation of Miami are being recalled because the needles may detach from the syringes during use, posing a threat of injury to users, the Food and Drug Administration said.
Continue →GE Warned Over Misleading Claims on Imaging Drug
The Food and Drug Administration has warned General Electric Co’s healthcare unit about misleading claims the company made about one of its medical imaging drugs on a promotional website.
Continue →Stryker Pain Pump Injury Lawsuit Filed
A Las Vegas woman has filed a federal lawsuit against Stryker Corp. for injuries she claims were caused by the use of a defective pain pump.
Continue →Minn. Medical Device Maker Agrees to Shut Down
Medical device manufacturer Sybaritic Inc. has agreed to stop making products used in laser surgery, spa treatment, and dermatology procedures until the company complies with Food and Drug Administration safety regulations, officials said.
Continue →Catheters Recalled: May Crack and Injure Patients, FDA Warns
Catheters made by Endovascular, Inc. are being recalled today because the defective medical devices may crack and cause serious injury or death to patients, the Food and Drug Administration said.
Continue →U.S. Medical Device Maker Agrees to $5 Million Penalty
A Colorado-based medical device maker has agreed to pay $5 million in fines stemming from charges the company illegally imported unapproved medical devices and falsely promoted them to doctors as being approved by the Food and Drug Administration.
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