Categories rss Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety CommunicationMurilo Freitas - 17:00, 2 de February de 2026451 0 FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-lead-test-results-certain-capillary-blood-collection-tubes-used-magellan
Categories rss Early Alert: Heart Pump Issue from AbiomedMurilo Freitas - 05:00, 2 de February de 2026174 0 The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift. http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-issue-abiomed
Categories rss FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical ManufacturingMurilo Freitas - 15:13, 31 de January de 2026162 0 FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturinghttp://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing
Categories rss Early Alert: Wound and Burn Dressing Issue from Integra LifeSciencesMurilo Freitas - 05:00, 21 de January de 2026322 0 Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriers http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-wound-and-burn-dressing-issue-integra-lifesciences
Categories rss Early Alert: Insufflation Unit Issue from OlympusMurilo Freitas - 05:00, 21 de January de 2026304 0 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/early-alert-insufflation-unit-issue-olympus
Categories rss FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of EntryMurilo Freitas - 15:00, 20 de January de 2026219 0 FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entryhttp://www.fda.gov/news-events/press-announcements/fda-importshield-program-delivers-impressive-results-strengthening-fda-oversight-us-ports-entry
Categories rss FDA Takes Steps to Improve Gluten Ingredient Disclosure in FoodsMurilo Freitas - 14:33, 20 de January de 2026152 0 FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foodshttp://www.fda.gov/news-events/press-announcements/fda-takes-steps-improve-gluten-ingredient-disclosure-foods
Categories rss Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 VaporizersMurilo Freitas - 05:00, 15 de January de 2026367 0 Draeger is removing certain Vapor 2000 and Vapor 3000 Vaporizers due to impurities found within a component. http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthetic-vaporizer-recall-draeger-removes-vapor-2000-and-vapor-3000-vaporizers
Categories rss Early Alert: Broselow Rainbow Tape Issue from AirLifeMurilo Freitas - 05:00, 15 de January de 2026178 0 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/early-alert-broselow-rainbow-tape-issue-airlife
Categories rss Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit KitsMurilo Freitas - 05:00, 15 de January de 2026362 0 Medline is removing certain anesthesia circuit kits due to cracks and leaks in the tubing. http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-kit-recall-medline-removes-anesthesia-circuits-and-anesthesia-circuit-kits
