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Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or death
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Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.
Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This voluntary action applies to all SpeedControl Dials manufactured and distributed between the dates of Ap
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DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination
DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.
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FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
http://www.fda.gov/news-events/press-announcements/fda-commissioner-makary-usda-secretary-rollins-celebrate-proposed-modernization-orange-juice
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A Statement from FDA Commissioner Marty Makary, M.D., M.P.H.: Announcing Resolution of the IV Saline Solutions Shortage
A Statement from FDA Commissioner Marty Makary, M.D., M.P.H.: Announcing Resolution of the IV Saline Solutions Shortage
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-announcing-resolution-iv-saline-solutions-shortage
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FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
http://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing
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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication
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Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy
BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.
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Early Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters