Blog – Page 2 – PRAIS 2.0

Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Murilo Freitas - 05:00, 25 de December de 2025200

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gold-star-distribution-inc-issues-recall-certain-fda-regulated-products-three-states-including-drugs

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Early Alert: Convenience Kit Needle Issue from Integra LifeSciences

Murilo Freitas - 05:00, 22 de December de 2025144

Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-needle-issue-integra-lifesciences

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Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft

Murilo Freitas - 05:00, 22 de December de 2025164

Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endovascular-graft-recall-cook-medical-removes-zenith-alpha-2-thoracic-endovascular-graft

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MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

Murilo Freitas - 05:00, 22 de December de 202594

Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/mri-system-correction-siemens-healthineers-issues-correction-3-tesla-mri-systems

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