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Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

Murilo Freitas - 04:00, 17 de July de 202516

Manual resuscitator recalled due to incorrect B/V filter assembly that could delay therapy. May cause hypoxia, hypercapnia, or death if used.

http://www.fda.gov/medical-devices/medical-device-recalls/manual-resuscitator-recall-sunmed-holdings-llc-removes-adult-manual-resuscitator-devices-due

Paraguay establece Mesa Consultiva para fortalecer la atención primaria de salud con apoyo de la OPS, Banco Mundial y el BID

admin - 14:00, 16 de July de 202535

Paraguay establishes advisory council to strengthen primary health care with support from PAHO, World Bank, and IDB

Cristina Mitchell

17 Jul 2025

Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc.

Murilo Freitas - 04:00, 16 de July de 202533

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-microbore-extension-set-issue-b-braun-medical-inc

Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming Hot to the Touch and/or Melting While Being Used

Murilo Freitas - 04:00, 16 de July de 202523

Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used.

http://www.fda.gov/medical-devices/medical-device-recalls/portable-oxygen-concentrator-car-adapter-recall-drive-devilbiss-healthcare-removes-igo-dv6x-619-dc

BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies

Murilo Freitas - 04:00, 16 de July de 202528

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-issues-update-voluntary-global-recall-alaristm-and-bd-alaristm-pump-modules-serviced-legacy-bezel

Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels

Murilo Freitas - 04:00, 16 de July de 202528

Dexcom recalls certain receivers that may fail to sound alerts. Missed alerts could delay detection of severe blood sugar events, causing seizures or death.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-glucose-monitor-receiver-recall-dexcom-inc-removes-certain-dexcom-g6-g7-one-and-one

FDA to Revoke 52 Obsolete Standards of Identity for Food Products

Murilo Freitas - 15:23, 15 de July de 202528

FDA to Revoke 52 Obsolete Standards of Identity for Food Products
http://www.fda.gov/news-events/press-announcements/fda-revoke-52-obsolete-standards-identity-food-products

Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly

Murilo Freitas - 04:00, 15 de July de 202535

Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.

http://www.fda.gov/medical-devices/medical-device-recalls/cranial-drill-recall-integra-lifesciences-recalls-codman-disposable-perforators-due-risk-device

Major Storm on the Horizon: NCDs and mental health conditions to cost South America trillions by 2050

admin - 16:52, 14 de July de 202534

Major Storm on the Horizon: NCDs and mental health conditions to cost South America trillions by 2050

Cristina Mitchell

15 Jul 2025

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

Murilo Freitas - 14:01, 14 de July de 202540

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine

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