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Recent Posts in Recalls Category

  • FDA ISSUES RECALL NOTICE ABOUT QUEST MEDICAL'S MPS DELIVERY SETS

    The FDA recently warned healthcare professionals of a recall of MPS Delivery Sets by Quest Medical, Inc. The Sets are used to deliver solutions to the heart during cardiopulmonary bypass surgeries. Quest Medical has recalled certain lots of these defective medical devices that were distributed between June 2015 and September 2015. The reason for the nationwide recall is a "seal failure along the ...
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  • FDA ISSUES RECALL NOTICE ABOUT SYNCARDIA'S FREEDOM DRIVER SYSTEM

    The FDA recently warned healthcare professionals of a recall of Freedom Driver System by SynCardia Systems. The Freedom Driver System operates and monitors SynCardia's Total Artificial Heart, which serves as a temporary "mechanical replacement for a patient's heart." SynCardia Systems has recalled certain lots of these defective medical devices that were distributed between November 2014 and July ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL'S ENDOBRONCHIAL TUBES

    The FDA recently warned healthcare professionals of a recall of Hudson RCI Endobronchial Tube by Teleflex Medical. These tubes are inserted through the mouth into the bronchi of the lungs and are "used during a medical procedure that determines how well a lung is working." In the US alone, Teleflex Medical has recalled over 62,000 of these defective medical devices that were distributed between ...
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  • FDA ISSUES RECALL NOTICE ABOUT COOK MEDICAL'S ANGIOGRAPHIC CATHETERS

    By Kaiser Gornick LLP posted in Defective Medical Devices on Monday, August 17, 2015 The FDA recently warned healthcare professionals of a recall of Beacon Tip Angiographic Catheters by Cook Medical. These angiographic catheters "are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions." In the US alone, Cook Medical has ...
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  • FDA ISSUES RECALL NOTICE ABOUT TIGERPAW SYSTEM II

    The FDA recently warned healthcare professionals of a recall of TigerPaw System II by Maquet Medical Systems. The TigerPaw System II "is a surgical staple used to close tissue in the left atrial appendage," a muscular ear-shaped pouch in the heart. Maquet Medical Systems has recalled all lots of these medical devices that were distributed between April 2013 and March 2015. The reason for the ...
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  • FDA ISSUES RECALL NOTICE ABOUT MYLAN INJECTABLE PRODUCTS

    The FDA recently warned healthcare professionals of a recall of various injectable medications by Mylan N.V. These pharmaceuticals include gemcitabine, carboplatin, methotrexate, and cytarabine, which are mostly used to treat various types of cancer. Mylan has recalled certain lots of these injectable products that were distributed in 2014. The reason for the nationwide recall is "the presence of ...
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  • FDA ISSUES RECALL NOTICE ABOUT HOSPIRA INFUSION PUMPS

    The FDA recently warned healthcare professionals of a recall of Plum A+ and Plum A+3 Infusion Systems by Hospira. These devices are used to deliver fluids, including "critical intravenous medication... into a patient's body in controlled amounts." Hospira has recalled infusion pumps manufactures and distributed between July 2012 and May 2014. The reason for the recall is faulty alarms that may ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL MAQUET SERVO HUMIDIFIER

    The FDA recently warned healthcare professionals of a recall of MAQUET Servo Humidifier 163 by Teleflex Medical. These devices are "placed over a surgically-created opening in the throat or a tube inserted into the trachea to warm and moisten gases breathed in by a patient." Teleflex Medical has recalled certain lots of the humidifiers distributed between June 2013 and November 2014. The reason ...
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  • FDA ISSUES RECALL NOTICE ABOUT KIMVENT* MICROCUFF* ENDOTRACHEAL TUBES

    The FDA recently warned healthcare professionals of a recall of Halyard Health's KimVent* Microcuff* Endotracheal Tubes. These devices are plastic tubes "inserted into the windpipe (trachea)... to open an airway for mechanical breathing [or]... to remove fluid that builds up in the windpipe during a procedure." Halyard Health has recalled endotracheal tubes distributed between December 2013 and ...
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  • FDA ISSUES RECALL NOTICE ABOUT GEMSTAR INFUSION PUMP POWER SUPPLY

    The FDA recently warned healthcare professionals of a recall of Hospira's Wall Mount and Desk Top GemStar Power Supplies. These accessories provide power to the GemStar Infusion Pump, which is "used to deliver controlled amounts of fluids including medicines, blood, [and] nutritional foods... into a patient's body..." Hospira has recalled power supplies distributed between November 2011 and April ...
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  • FDA ISSUES RECALL NOTICE ABOUT PEDIATRIC ANESTHESIA BREATHING DEVICE

    The FDA recently warned healthcare professionals of a recall of Teleflex Medical's Hudson RCI Pediatric Anesthesia Breathing Circuits. These medical devices are used to administer medical gases to pediatric patients during anesthesia. Teleflex Medical has recalled breathing circuits with certain lot numbers distributed between June 2013 and May 2014. The reason for the recall is a defect that ...
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  • FDA ISSUES RECALL NOTICE ABOUT CARDIOVASCULAR SYSTEMS' DIAMONDBACK 360 BLOOD VESSEL TOOL

    The FDA recently warned healthcare professionals of a recall of Diamondback 360 Peripheral Orbital Atherectomy Systems. This medical device is inserted into patients' blood vessels and used "to reestablish blood flow in narrowed arteries." Cardiovascular Systems has recalled certain lot numbers of the device since "they may contain defective saline sheaths that could fracture during use." The ...
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  • FDA ISSUES RECALL NOTICE ABOUT CUBICIN

    The FDA recently warned healthcare professionals of a recall of Cubist Pharmaceuticals' Cubicin (daptomycin for injection). Cubicin is an intravenous antibiotic prescribed "for the treatment of skin infections and certain blood stream infections." Cubist Pharmaceuticals has recalled nine lots of Cubicin shipped between September 2013 and December 2013 due to the presence of foreign particulate ...
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  • FDA ISSUES RECALL NOTICE ABOUT GE'S E-MINIC CO2 DETECTORS

    The FDA recently warned healthcare professionals of a recall of GE Healthcare E-miniC Airway Modules and accessories. These medical devices are used in "health care facilities for monitoring CO2 [carbon dioxide] and respiration rates in patients weighing over 11 pounds." GE Healthcare has recalled modules with certain serial numbers because of a defect that could cause them to fail or provide ...
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  • GENERAL MOTORS RECALLS OVER 2 MILLION VEHICLES DUE TO FAULTY IGNITION SWITCH

    On February 13, 2014, General Motors Company (GM) announced a recall of Chevrolet Cobalt and Pontiac G5 vehicles (models 2005 through 2007). The recall was prompted by problems with the ignition switch that could cause the key to unintentionally turn to the "off" or "accessory" positions, which in turn results in loss of power to the engine and various electrical components. In addition, airbags ...
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  • Voluntary Recall Of Estarylla Tablets

    A recent posting by the FDA informs that Sandoz, a Division of the Novartis group, has issued a voluntary recall of a batch of Estarylla tablets. Estarylla (norgestimate and ethinyl estradiol) is a combination oral contraceptive. The recall was prompted by a packaging flaw. In particular, the affected lot had placebo tablets mixed with regular tablets containing the active ingredients. According ...
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