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Early Alert: Diagnostic Intravascular Catheter Issue from Conavi
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product
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FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
http://www.fda.gov/news-events/press-announcements/fda-commissioner-makary-announces-new-policy-individuals-serving-fda-advisory-committees
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FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus
FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus
http://www.fda.gov/news-events/press-announcements/fda-honored-welcome-hhs-secretary-robert-f-kennedy-jr-fda-campus
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FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
http://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
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Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User
Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav
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Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.
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Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner
Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner
http://www.fda.gov/news-events/press-announcements/martin-makary-md-mph-sworn-fda-commissioner
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Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer
Aortic Root Cannulas are used during heart surgery. There is a risk of extra material in the device due to a manufacturing error.
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Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.
