rss – PRAIS 2.0

Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds

Murilo Freitas - 05:00, 12 de February de 202625

Medline updates use instructions for Electronic Homecare Beds due to risk of electrical fires and entrapment.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/electronic-homecare-bed-correction-medline-updates-use-instructions-homecare-beds

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

Murilo Freitas - 16:17, 11 de February de 202638

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products
http://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products

FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer

Murilo Freitas - 13:33, 11 de February de 202643

FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
http://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer

Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers

Murilo Freitas - 05:00, 10 de February de 202643

AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/emergency-response-safety-kit-recall-airlife-removes-certain-broselow-pediatric-emergency-rainbow

FDA Launches Assessment of BHA, a Common Food Chemical Preservative

Murilo Freitas - 14:13, 9 de February de 202648

FDA Launches Assessment of BHA, a Common Food Chemical Preservative
http://www.fda.gov/news-events/press-announcements/fda-launches-assessment-bha-common-food-chemical-preservative

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs

Murilo Freitas - 21:43, 5 de February de 2026144

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs
http://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs

Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX® Blood Glucose Monitoring Systems

Murilo Freitas - 05:00, 5 de February de 2026120

FT. LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monit

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-initiates-labeling-correction-all-true-metrixr-blood-glucose-monitoring-systems

FDA Takes New Approach to “No Artificial Colors” Claims

Murilo Freitas - 14:07, 4 de February de 202652

FDA Takes New Approach to “No Artificial Colors” Claims

http://www.fda.gov/news-events/press-announcements/fda-takes-new-approach-no-artificial-colors-claims

Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Murilo Freitas - 05:00, 4 de February de 202651

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/glucose-monitor-sensor-recall-abbott-diabetes-care-removes-certain-freestyle-libre-3-and-freestyle

Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System

Murilo Freitas - 05:00, 4 de February de 2026169

MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rate

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/detachable-coil-system-recall-jj-medtechcerenovus-inc-remove-cerepak-detachable-coil-system