Murilo Freitas – Page 11

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 2025165

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

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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 2025171

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

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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 2025339

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

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FDA to Revoke 52 Obsolete Standards of Identity for Food Products

Murilo Freitas - 15:23, 15 de July de 2025190

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

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

Murilo Freitas - 04:00, 15 de July de 2025233

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

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

Murilo Freitas - 14:01, 14 de July de 2025181

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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Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

Murilo Freitas - 04:00, 14 de July de 2025387

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

http://www.fda.gov/medical-devices/medical-device-recalls/endoscopic-vessel-harvesting-evh-system-correction-getinge-and-maquet-cardiovascular-update-use

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Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers

Murilo Freitas - 04:00, 14 de July de 2025298

The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.

http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-availability-concerns-vasoview-hemopro-endoscopic-vessel-harvesting-systems-letter-health

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FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

Murilo Freitas - 12:59, 13 de July de 2025191

FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

http://www.fda.gov/news-events/press-announcements/fda-approves-gardenia-genipin-blue-color-additive-while-encouraging-faster-phase-out-fdc-red-no-3

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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Murilo Freitas - 04:00, 13 de July de 2025192

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-sucralfate-tablets-usp-1-gram-within