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Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software

Murilo Freitas - 05:00, 24 de February de 2026138
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Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-pump-software-correction-fresenius-kabi-issues-correction-ivenix-large-volume-pump-software

 
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Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems

Murilo Freitas - 05:00, 24 de February de 2026141
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Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/stent-recall-boston-scientific-removes-certain-axios-stents-and-electrocautery-enhanced-delivery

 
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FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases

Murilo Freitas - 16:32, 22 de February de 202695
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FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases
http://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases

 
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Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units

Murilo Freitas - 05:00, 22 de February de 2026146
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Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insufflation-unit-recall-olympus-removes-high-flow-insufflation-units

 
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Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems

Murilo Freitas - 05:00, 16 de February de 2026140
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Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately  

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-trividia-health-issues-correction-true-metrix-blood-glucose-monitoring-systems

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

Murilo Freitas - 05:00, 12 de February de 202695
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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

 
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FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

Murilo Freitas - 16:17, 11 de February de 2026115
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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

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

Murilo Freitas - 13:33, 11 de February de 2026133
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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

 
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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 2026126
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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

 
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FDA Launches Assessment of BHA, a Common Food Chemical Preservative

Murilo Freitas - 14:13, 9 de February de 2026122
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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

 
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