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Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples. Risk Statement: Administration of an injectable pro
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FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic Syndromes
FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic Syndromes
http://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-form-blood-cancers-called-myelodysplastic-syndromes
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FDA Roundup: October 24, 2023
FDA Roundup: October 24, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-24-2023
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Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds
Fresenius Medical Care 2008 Series Hemodialysis Machines are recalled for the potential for toxic compounds leaching from chlorinated peroxide cured silicone tubing.
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FDA Roundup: October 20, 2023
FDA Roundup: October 20, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-20-2023
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Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards
Philips Respironics recalls V60 and V60 Plus Ventilators because the PM PCBAs do not conform with ventilators standards.
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FDA Deputy Commissioner for Human Foods Commits to Fulfilling Vision of Proposed Program
FDA Deputy Commissioner for Human Foods Commits to Fulfilling Vision of Proposed Program
http://www.fda.gov/news-events/press-announcements/fda-deputy-commissioner-human-foods-commits-fulfilling-vision-proposed-program
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Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes
Medtronic is issuing this notification to inform the public of stolen defective McGRATH™ MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. These affected products did not pass Medtronic’s rigorous quality tests est
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Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits
Hamilton recalls their HAMILTON-C1, T1, MR-1 ventilators for capacitators that may leak electrolyte onto the control board and cause short circuiting.
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Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication
Universal Meditech, Inc has notified FDA that it has stopped all operations. Their tests should not be used.