Murilo Freitas – PRAIS 2.0

Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Murilo Freitas - 04:00, 9 de October de 202535

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-automated-impella-controller-correction-due-cybersecurity-issue-abiomed

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Murilo Freitas - 04:00, 9 de October de 202529

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

http://www.fda.gov/safety/medical-product-safety-information/fda-approves-labeling-changes-include-boxed-warning-immune-effector-cell-associated-enterocolitis

Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters

Murilo Freitas - 04:00, 6 de October de 202543

(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-initiates-voluntary-recall-limited-number-true-metrixr-blood-glucose-meters

FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in Cattle

Murilo Freitas - 18:09, 29 de September de 202557

FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in Cattle
http://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-drug-prevention-and-treatment-new-world-screwworm-infestations

A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes

Murilo Freitas - 13:00, 29 de September de 202548

A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-encouraging-retailers-stop-selling-illegal-vapes

Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips

Murilo Freitas - 04:00, 29 de September de 2025113

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endoscopic-aspiration-needle-recall-olympus-removes-certain-vizishot-2-flex-19g-needles-due

What is a Medical Device Recall?

Murilo Freitas - 12:47, 28 de September de 202562

What is a Medical Device Recall?

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/what-medical-device-recall

Update on Alert: Infusion Set Performance Issue from BD

Murilo Freitas - 04:00, 28 de September de 202551

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

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/update-alert-infusion-set-performance-issue-bd

Recall and Alert Resources

Murilo Freitas - 04:00, 28 de September de 202546

.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices
 

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-and-alert-resources

Early Alert: Infusion Set Performance Issue from BD

Murilo Freitas - 04:00, 25 de September de 2025217

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-infusion-set-performance-issue-bd

PRAIS 2.0