Murilo Freitas – PRAIS 2.0

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

Murilo Freitas - 18:20, 23 de April de 202522

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

http://www.fda.gov/medical-devices/medical-device-recalls/heart-pump-accessory-removal-abbott-removes-heartmate-mobile-power-unit-due-instances-sudden-power

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Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

Murilo Freitas - 16:00, 23 de April de 202518

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-results-certain-capillary-blood-collection-tubes-used-magellan-diagnostics

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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply

Murilo Freitas - 20:12, 21 de April de 202534

HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
http://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply

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Early Alert: Intravascular PICC Catheter Issue from BD

Murilo Freitas - 16:52, 17 de April de 202550

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-intravascular-picc-catheter-issue-bd

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Early Alert: Diagnostic Intravascular Catheter Issue from Conavi

Murilo Freitas - 14:25, 17 de April de 202555

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-diagnostic-intravascular-catheter-issue-conavi

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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

Murilo Freitas - 04:00, 17 de April de 202547

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

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072

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FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

Murilo Freitas - 18:59, 16 de April de 202558

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

Murilo Freitas - 21:01, 10 de April de 202567

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

Murilo Freitas - 19:33, 9 de April de 202586

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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Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.

Murilo Freitas - 04:00, 6 de April de 202567

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.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar