http://www.fda.gov/ en 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, 28 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers http://www.fda.gov/medical-devices/letters-health-care-providers/update-nuvasive-specialized-orthopedics-precice-devices-letter-health-care-providers The FDA is updating recommendations for the Intra-medullary Limb Lengthening Device. Wed, 28 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-nuvasive-specialized-orthopedics-precice-devices-letter-health-care-providers http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-recall-arrow-endurance-extended-dwell-peripheral-catheter-system The ARROW Endurance Extended Dwell Peripheral Catheter System is being recalled after reports of catheter separation and leakage. Mon, 26 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-recall-arrow-endurance-extended-dwell-peripheral-catheter-system http://www.fda.gov/medical-devices/safety-communications/do-not-use-ultraviolet-uv-wands-give-unsafe-levels-radiation-fda-safety-communication UV wands may cause injury to the skin, eyes, or both after a few seconds of use. Mon, 26 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-ultraviolet-uv-wands-give-unsafe-levels-radiation-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Mon, 26 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/medical-devices/safety-communications/actualizacion-de-los-sistemas-endovasculares-de-injerto-de-aaa-endologix-afx-y-el-riesgo-de-endofuga La nueva etiqueta del sistema endovascular AFX2 para AAA (AFX2) incluye información para informar mejor a los pacientes y a los profesionales de la salud sobre el riesgo de endofugas de tipo III. Thu, 15 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/actualizacion-de-los-sistemas-endovasculares-de-injerto-de-aaa-endologix-afx-y-el-riesgo-de-endofuga http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-dronabinol-capsules-usp-25-mg-and The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group, LLC received a customer complaint from a dis Wed, 14 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-dronabinol-capsules-usp-25-mg-and 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. Tue, 13 Jun 2023 00:00:00 EDT 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/bearcare-inc-recalls-rechargeable-walnut-wearable-smart-thermometers-risks-serious-injury-including The rechargeable Walnut Thermometer is used at home for infants and children 0 to 6-years-old. It may cause burns, skin irritation or other injury when used. Mon, 12 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/bearcare-inc-recalls-rechargeable-walnut-wearable-smart-thermometers-risks-serious-injury-including http://www.fda.gov/medical-devices/letters-health-care-providers/oxygenator-devices-used-extracorporeal-circulation-letter-health-care-providers Learn about the issue, the FDA's recommendations and actions, how to report a problem, and contact information. Fri, 09 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/oxygenator-devices-used-extracorporeal-circulation-letter-health-care-providers 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, 07 Jun 2023 00:00:00 EDT 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/medical-devices/medical-device-recalls/abiomed-recalls-specific-impella-55-smartassist-purge-fluid-leaks-can-cause-pump-stop-and-loss Impella provides short-term pumping support to the heart. Purge fluid leaks may cause the pump to stop providing necessary therapy for critical patients. Mon, 05 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-specific-impella-55-smartassist-purge-fluid-leaks-can-cause-pump-stop-and-loss http://www.fda.gov/medical-devices/letters-health-care-providers/non-sterile-single-use-pneumatic-tourniquet-cuffs-conservation-strategies-letter-health-care Read the recommendations for health care facilities and providers due to localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs. Mon, 05 Jun 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/non-sterile-single-use-pneumatic-tourniquet-cuffs-conservation-strategies-letter-health-care 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. Fri, 02 Jun 2023 00:00:00 EDT 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/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 Fri, 02 Jun 2023 00:00:00 EDT 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/2023-safety-communications Listing of Medical Device 2023 Safety Communications Tue, 30 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/safety/medical-product-safety-information/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants. Fri, 26 May 2023 12:28:00 EDT FDA http://www.fda.gov/safety/medical-product-safety-information/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions http://www.fda.gov/medical-devices/medical-device-recalls/sd-biosensor-inc-recalls-certain-pilot-covid-19-home-tests-potential-bacteria-contamination SD BioSensor is recalling some Pilot COVID-19 At-Home Tests for the risk that a bacteria contamination could harm users or cause false test results. Thu, 25 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/sd-biosensor-inc-recalls-certain-pilot-covid-19-home-tests-potential-bacteria-contamination http://www.fda.gov/medical-devices/medical-device-recalls/draeger-medical-recalls-seattle-pap-plus-and-breathing-circuitanesthesia-kits-risk-loose-or-detached Draeger Seattle PAP Plus and some breathing circuit or anesthesia kits may have parts that loosen or detach, preventing needed breathing support. Wed, 24 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/draeger-medical-recalls-seattle-pap-plus-and-breathing-circuitanesthesia-kits-risk-loose-or-detached http://www.fda.gov/medical-devices/medical-device-recalls/icu-medical-recalls-replacement-batteries-plum-360-plum-and-plum-a3-infusion-systems-due-diminished Replacement batteries for ICU Medical’s Plum 360, Plum A+ and Plum A+3 large volume infusion pumps may have shorter than expected battery life. Mon, 22 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/icu-medical-recalls-replacement-batteries-plum-360-plum-and-plum-a3-infusion-systems-due-diminished