Murilo Freitas – Page 3 – PRAIS 2.0

Correction Alert: Olympus Updates Use Instructions for Ligating Device

Murilo Freitas - 05:00, 2 de December de 2025144

Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
 

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-olympus-updates-use-instructions-ligating-device

FDA Seizes 7-OH Opioids to Protect American Consumers

Murilo Freitas - 21:41, 1 de December de 2025100

FDA Seizes 7-OH Opioids to Protect American Consumers
http://www.fda.gov/news-events/press-announcements/fda-seizes-7-oh-opioids-protect-american-consumers

FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies

Murilo Freitas - 14:58, 1 de December de 202564

FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
http://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-reducing-testing-non-human-primates-monoclonal-antibodies

Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care

Murilo Freitas - 05:00, 1 de December de 2025147

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care

FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

Murilo Freitas - 20:04, 30 de November de 2025153

FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
http://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment

Recall Alert: Glycar SA Removes Pericardial Patch

Murilo Freitas - 05:00, 30 de November de 202572

Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-glycar-sa-removes-pericardial-patch

Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue

Murilo Freitas - 05:00, 27 de November de 2025118

Dropping or severely jarring Alaris Pumps may damage critical pump components. Do not use dropped or jarred devices until thoroughly inspected and tested

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-becton-dickinson-updates-use-instructions-bd-alaris-pump-issue

Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

Murilo Freitas - 05:00, 25 de November de 202575

Balt USA is removing their Mega Ballast because of the unintended presence of loose hydrophilic coating inside the tube at the tip end

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-balt-usa-removes-mega-ballast-distal-access-platform

Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

Murilo Freitas - 05:00, 25 de November de 202577

Baxter is permanently removing all Life2000 Ventilation Systems after discovering a cybersecurity issue that may allow unauthorized access to the device

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-baxter-permanently-removes-life2000-ventilation-system

Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices

Murilo Freitas - 05:00, 24 de November de 202562

SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-max-mobilitypermobil-removes-all-speedcontrol-dials-used-smartdrive-mx2-power-assist

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