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Early Alert: Nephroscope Sheath Issue from Trokamed GmbH

Murilo Freitas - 05:00, 19 de December de 2024169

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-nephroscope-sheath-issue-trokamed-gmbh

FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers

Murilo Freitas - 16:39, 18 de December de 2024168

FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
http://www.fda.gov/news-events/press-announcements/fda-updates-healthy-claim-providing-refreshed-tool-consumers

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

Murilo Freitas - 21:40, 17 de December de 2024191

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
http://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host

Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

Murilo Freitas - 05:00, 17 de December de 2024366

Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices.

http://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices

Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications

Murilo Freitas - 05:00, 17 de December de 2024178

BioZorb Markers are implantable and used to mark soft tissue for procedures. They are being recalled after reports of patient complications.

http://www.fda.gov/medical-devices/medical-device-recalls/implantable-marker-recall-hologic-removes-biozorb-3d-bioabsorbable-markers-due-risk-patient

Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

Murilo Freitas - 05:00, 17 de December de 2024133

The FDA’s updated information about BioZorb Marker.

http://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication

Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula

Murilo Freitas - 05:00, 17 de December de 2024196

POLARx Cryoablation Balloon Catheters treat atrial fibrillation. After reports of atrio-esophageal fistula, the use instructions are being updated.

http://www.fda.gov/medical-devices/medical-device-recalls/catheter-correction-boston-scientific-updates-use-instructions-polarx-and-polarx-fit-cryoablation

Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide

Murilo Freitas - 05:00, 17 de December de 2024230

December 16, 2024 – Los Angeles, California – Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See Attachment 1 for photo of product labeling. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and effi

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shoppers-plaza-issues-voluntary-nationwide-recall-fouzee-sugarlin-herbal-formula-due-presence

FDA Roundup: December 17, 2024

Murilo Freitas - 21:20, 16 de December de 2024206

FDA Roundup: December 17, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-17-2024

PAHO’s year in health: 10 highlights from 2024

admin - 20:55, 16 de December de 2024274

PAHO’s year in health: 10 highlights from 2024

Cristina Mitchell

17 Dec 2024

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