Medical Device recall alerts and consumer safety news updated hourly http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices Thu, 27 Feb 2014 14:08:21 +0100 http://www.recallowl.com/images/rss.gif http://www.recallowl.com The feed is managed/created by RecallOwl.com (http://www.recallowl.com). http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Philips+Respironics+Initiates+Recall+of+Trilogy+Ventilator - February 19, 2014 - Murrysville, PA - Respironics, Inc., a Philips Healthcare business, today announced a worldwide recall of approximately 600 Philips Respironics Trilogy Ventilators, comprising Trilogy Ventilator Models 100, 200 and 202. On February 11, 2014, Philips Respironics initiated a voluntary recall to address a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of t... Wed, 19 Feb 2014 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Nipro+Diagnostics%2C+Inc.+Initiates+Voluntary+Recall+of+Certain+TRUEbalance+and+TRUEtrack+Blood+Glucose+Meters - January 2, 2014 - Fort Lauderdale, FL-Nipro Diagnostics, Inc. today announced it is initiating a voluntary recall and replacement of a limited number of TRUEbalance™ and TRUEtrack® Blood Glucose Meters distributed both in the United States and outside the United States. The company has determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters distributed in the United States have an incorrect factory-set unit o... Tue, 07 Jan 2014 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Voluntary+Field+Corrective+Action+Initiated+for+Vital+Signs+Device%26%23226%3B%26%238364%3B%26%238482%3Bs+CO2+Multi+Absorber+Due+to+a+Health+Risk - December 30, 2013 - Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. The Multi Absorber Original may have a thin wall condition which may lead to small holes in the water (drain tube). This may result in a loss of anesthetic gases, ventilation and ox... Wed, 01 Jan 2014 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Abrams+Royal+Pharmacy+Issues+Voluntary+Nationwide+Recall+of+All+Lots+of+Unexpired+Sterile+Products+Due+to+Lack+of+Sterility+Assurance - December 18, 2013 - Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall. Sterile products are injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments. All recalled products have a label that includes Abrams R... Thu, 19 Dec 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Abbott+Issues+Voluntary+Recall+of+Certain+FreeStyle%26%23174%3B+and+FreeStyle+Lite%26%23174%3B+Blood+Glucose+Test+Strips+in+the+United+States - November 27, 2013 - Abbott today announced it is initiating a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both "FreeStyle® Blood Glucose Meter" and "FreeStyle® Flash Blood Glucose Meter" [neither of which have been in production since 2010], as well as the OmniPod® Insulin Management System... Wed, 27 Nov 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/CLR+Medicals+International+Inc.+Issues+Nationwide+Recall+of+Viscoelastic+Products - November 25, 2013 - CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been d... Mon, 25 Nov 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Dr%26%23228%3Bger+issues+an+update+on+its+voluntary+recall+of+Fabius+anesthesia+machines - October 7, 2013 - Today Dr㦥r issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. Dr㦥r initiated this voluntary action in August of 2013 as a result of an internal investigation into devices that did not pass the high voltage test portion of the final production test. This recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius Tiro, and 1 Fabius Tiro D-M anesthesia machines m... Tue, 08 Oct 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/ForeCYTE+Breast+Health+Test%3B+Mammary+Aspiration+Specimen+Cytology+Test+%28MASCT%29 - October 4, 2013 -Atossa Genetics Inc. (NASDAQ: ATOS) initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. This voluntary recall includes the MASCT System Kit and Patient Sample Kit. The vast majority of these products (approximately ninety percent) are in inventory with Atossa's distributors and the remaining quantities are at customer sites acro... Fri, 04 Oct 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Voluntary+Recall+of+Specified+Lots+of+Nova+Max%26reg%3B+Glucose+Test+Strips - July 26, 2013 - Nova Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall. The company has recently determined that some of the blood glucose test strips contained within the indicated Nova... Mon, 29 Jul 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Medtronic+Issues+Medical+Device+Notifications+Regarding+The+Synchromed+Implantable+Infusion+System - June 26, 2013 - MINNEAPOLIS - In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System. The United States Food and Drug Administration (FDA) has ... Fri, 28 Jun 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Respironics+California%2C+Inc.+Recall+of+V60+Ventilator+Designated+Class+I+by+FDA - June 25, 2013 - Respironics California, Inc., a Philips Healthcare business, today announced that the company's worldwide recall of approximately 19,200 Philips Respironics V60 Ventilators has been designated a Class I recall by the U.S. Food and Drug Administration (FDA). On June 4, Respironics initiated a voluntary recall to correct a software issue that may cause the V60 ventilator device to shut down. Following FDA review, Respironics... Thu, 27 Jun 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Balanced+Solutions+Compounding+Pharmacy%2C+LLC.+Announces+a+Voluntary+Nationwide+Recall+of+All+Sterile+Compounded+Products+Due+to+a+Lack+of+Sterility+Assurance - April 17, 2013 - Balanced Solutions Compounding Pharmacy, LLC today announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance. Patients are at increased risk for infections in the event a sterile product is compromised. During a recent inspection the FDA... Sat, 20 Apr 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Covidien+Issues+Voluntary+Recall+of+Power+Pac+Batteries+for+Newport%26%238482%3B+HT70+and+HT70+Plus+Ventilators - April 18, 2013 - Covidien announced today that it notified customers on April 4, 2013, of a voluntary recall of certain Power Pac batteries for the Newport™ HT70 and HT70 Plus ventilators. This action was in response to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. These conditions have been... Thu, 18 Apr 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Abbott+Initiates+Voluntary+Recall+of+FreeStyle+lnsulinx%26%23174%3B+Blood+Glucose+Meters+in+the+United+States - Apri1 15, 2013 - Abbott today announced it is initiating a voluntary recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States. The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of 1066 mg/dL, the meter will dis... Wed, 17 Apr 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/FDA+Classifies+Voluntary+Shapematch%26reg%3B+Cutting+Guides+Recall+as+Class+I+Recall - April 10, 2013 - Stryker Corporation (NYSE:SYK) announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components... Wed, 10 Apr 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Ad-Tech+Medical+Instrument+Corporation+Issues+Global+Recall+of+Macro+Micro+Subdural+Electrodes - February 28, 2013 - On December 18, 2012 Ad-Tech Medical Instrument Corporation initiated a recall of 115 Macro Micro Subdural Electrodes. There is a concern the microelectrodes are not flush with the silastic surface. As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortica... Thu, 28 Feb 2013 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Zimmer+Spine+Issues+Urgent+Worldwide+Medical+Device+Recall+Of+The+Inserter+Instrument+For+The+PEEK+Ardis+Interbody+Spacer - December 20, 2012 - Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter. The Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. The inserters are being recalled because Zimmer Spine has received reports of PEEK Ardis Interbody Spacer implant breakage when the implant is subjected to excessive lateral and... Thu, 20 Dec 2012 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Bunnell+Incorporated+Issues+Nationwide+Recall+Notification+of+Life+Pulse+High-Frequency+Ventilator+Patient+Circuits -December 5 , 2012 - On December 12, 2012 Bunnell Incorporated will voluntarily initiate a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell's website, www.bunl.com. The product has been found to have heater wire insulation that can melt, causing sparking and smoke... Wed, 05 Dec 2012 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Verathon+Inc.+Issues+Voluntary+Recall+of+Certain+GlideScope+GVL+Video+Laryngoscope+Reusable+Blades - November 29, 2012 - Verathon Inc., Bothell, Washington, is initiating a voluntary recall of GlideScope GVL Video Laryngoscopes reusable blades that were manufactured between December 2010 and August 2011. These laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient's mouths and obstructing the airway or being ... Fri, 30 Nov 2012 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Bracco+Diagnostics+Inc.+Issues+Voluntary+Nationwide+Recall+of+Isovue%26%23174%3B+%28iopamidol+injection%29+Pre-Filled+Power+Injector+Syringes+due+to+Presence+of+Particulates - November 27, 2012 -Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant® CT Injection Systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples. BDI has received no reports of adverse events or customer complaints as... Wed, 28 Nov 2012 07:00:00 +0100