http://www.fda.gov/ en http://www.fda.gov/medical-devices/letters-health-care-providers/getingemaquet-cardiohelp-system-potential-insufficient-packaging-sterility-hls-set-advanced-letter Learn more about the issue with the HLS Set Advanced, background, FDA recommendations and FDA actions Wed, 01 Mar 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/getingemaquet-cardiohelp-system-potential-insufficient-packaging-sterility-hls-set-advanced-letter http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Wed, 01 Mar 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers http://www.fda.gov/medical-devices/safety-communications/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication Renuvion/J-Plasma device can be used for additional aesthetic skin procedures Mon, 27 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication http://www.fda.gov/medical-devices/safety-communications/actualizacion-uso-del-dispositivo-renuvionj-plasma-para-determinados-procedimientos-esteticos El dispositivo Renuvion/J-Plasma puede utilizarse para otros procedimientos estéticos de la piel Mon, 27 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/actualizacion-uso-del-dispositivo-renuvionj-plasma-para-determinados-procedimientos-esteticos http://www.fda.gov/medical-devices/letters-health-care-providers/abbott-trifecta-valves-potential-risk-early-structural-valve-deterioration-letter-health-care Learn more about the issue, recommendations, FDA actions and reporting problems to the FDA Mon, 27 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/abbott-trifecta-valves-potential-risk-early-structural-valve-deterioration-letter-health-care http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-delsam-pharma-artificial-eye-ointment Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. Use of contaminated eye ointment m Fri, 24 Feb 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-delsam-pharma-artificial-eye-ointment http://www.fda.gov/medical-devices/letters-health-care-providers/evaluation-airborne-chemicals-neonatal-incubators-letter-health-care-providers The FDA is evaluating the potential for exposure to airborne chemicals (formaldehyde, cyclohexanone, and other volatile chemicals) from neonatal incubators. Thu, 23 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/evaluation-airborne-chemicals-neonatal-incubators-letter-health-care-providers http://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients Safety mitigation issues including a failing ball screw and missing safety key may cause the 600/800 Series systems to fall on patients, leading to injury. Wed, 22 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nanomaterials-discovery-corporation-issues-voluntary-nationwide-recall-its-alcohol-antiseptic-80 Seattle, Washington, nanoMaterials Discovery Corporation is voluntarily recalling all lots of its Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue” in four fluid ounce spray dispenser packaging to the consumer level. Certain batches of the company’s Alcohol Antiseptic 80% Alcoho Tue, 21 Feb 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nanomaterials-discovery-corporation-issues-voluntary-nationwide-recall-its-alcohol-antiseptic-80 http://www.fda.gov/medical-devices/medical-device-recalls/magellan-diagnostics-recalls-leadcare-ii-leadcare-plus-and-leadcare-ultra-blood-lead-tests-due-risk The LeadCare tests are used to detect blood lead level but has risk of falsely low results. Fri, 17 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/magellan-diagnostics-recalls-leadcare-ii-leadcare-plus-and-leadcare-ultra-blood-lead-tests-due-risk http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Thu, 16 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/medical-devices/safety-communications/certain-reworked-philips-respironics-trilogy-100200-ventilators-recalled-due-potential-silicone-foam Certain reworked Trilogy ventilators have two recent issues that may cause blockage or debris in the airpath. Thu, 16 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/certain-reworked-philips-respironics-trilogy-100200-ventilators-recalled-due-potential-silicone-foam http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-philips-respironics-trilogy-100200-and-garbin Certain Philips Respironics Trilogy and Garbin ventilators are recalled due to foam adhesion failure and the risk of residual PE-PUR foam debris. Thu, 16 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-philips-respironics-trilogy-100200-and-garbin http://www.fda.gov/medical-devices/safety-communications/actualizacion-se-retiran-del-mercado-ciertos-ventiladores-maquinas-bipap-y-maquinas-cpap-de-philips ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA Wed, 15 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/actualizacion-se-retiran-del-mercado-ciertos-ventiladores-maquinas-bipap-y-maquinas-cpap-de-philips http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/volt-candy-issues-voluntary-nationwide-recall-primezen-black-6000-capsules-due-presence-sildenafil Pomona, California, Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FD Mon, 13 Feb 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/volt-candy-issues-voluntary-nationwide-recall-primezen-black-6000-capsules-due-presence-sildenafil http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-skippack-medical-lab-sars-cov-2-antigen-rapid-test Universal Meditech Inc. initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack o Fri, 10 Feb 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-skippack-medical-lab-sars-cov-2-antigen-rapid-test http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall Thu, 09 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. Thu, 09 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due http://www.fda.gov/medical-devices/safety-communications/do-not-use-skippack-medical-lab-sars-cov-2-antigen-rapid-test-fda-safety-communication The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests. The test’s performance has not been adequately established. Wed, 08 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-skippack-medical-lab-sars-cov-2-antigen-rapid-test-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not Universal Meditech Inc. recalls unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA. Wed, 08 Feb 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not