http://www.fda.gov/ en 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/2023-medical-device-recalls 2023 Medical Device Recalls Thu, 25 May 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/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 http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-emite-retiro-voluntario-de-gotas-pediatricas-g-supress-dx-debido-empaque-incorrecto San Juan, PR, Novis PR LLC está retirando voluntariamente el lote D20911 Exp 10/25 de gotas pediátricas G-Supress DX a nivel de consumidor. Se ha encontrado que algunas cajas del producto contienen un producto incorrecto en su interior. El producto incorrecto en el interior es un anestésico/analgési Fri, 19 May 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-emite-retiro-voluntario-de-gotas-pediatricas-g-supress-dx-debido-empaque-incorrecto http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-recall-g-supress-dx-pediatric-drops-due-incorrect-packaging San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR LLC. Fri, 19 May 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-recall-g-supress-dx-pediatric-drops-due-incorrect-packaging http://www.fda.gov/medical-devices/safety-communications/update-endologix-afx-endovascular-aaa-graft-systems-and-risk-type-iii-endoleak-fda-safety New labeling for AFX2 Endovascular AAA System (AFX2) includes information to better inform patients and health care providers of the risk of Type III endoleaks Wed, 17 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-endologix-afx-endovascular-aaa-graft-systems-and-risk-type-iii-endoleak-fda-safety http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bearcare-voluntarily-recalls-rechargeable-walnut-thermometer-due-potential-skin-burns BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitorin Fri, 12 May 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bearcare-voluntarily-recalls-rechargeable-walnut-thermometer-due-potential-skin-burns http://www.fda.gov/medical-devices/safety-communications/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication-0 Renuvion/J-Plasma device can be used for additional aesthetic skin procedures Wed, 10 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication-0 http://www.fda.gov/medical-devices/safety-communications/actualizacion-uso-del-dispositivo-renuvionj-plasma-para-determinados-procedimientos-esteticos-0 El dispositivo Renuvion/J-Plasma puede utilizarse para otros procedimientos cutáneos estéticos. Wed, 10 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/actualizacion-uso-del-dispositivo-renuvionj-plasma-para-determinados-procedimientos-esteticos-0 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 Wed, 10 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-notice-sd-biosensor-inc-requests-discontinuation-use-and-disposal-specific-pilottm-covid-19 SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected tests can be identified by the lot number on Fri, 05 May 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-notice-sd-biosensor-inc-requests-discontinuation-use-and-disposal-specific-pilottm-covid-19 http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test. Thu, 04 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication 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. Thu, 04 May 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/safety/recalls-market-withdrawals-safety-alerts/update-akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w Thu, 04 May 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry http://www.fda.gov/medical-devices/safety-communications/risk-exposure-unsafe-levels-radiation-safe-t-lite-uv-wand-fda-safety-communication Max-Lux Safe-T-Lite UV-C WAND may cause injury to the skin, eyes, or both after a few seconds of use. Thu, 04 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/risk-exposure-unsafe-levels-radiation-safe-t-lite-uv-wand-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/family-dollar-initiating-voluntary-recall-certain-over-counter-drug-products-because-products-have Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by Family Thu, 04 May 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/family-dollar-initiating-voluntary-recall-certain-over-counter-drug-products-because-products-have http://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-inc-recalls-certain-ballard-access-closed-suction-systems-neonatespediatrics-risk A cracked manifold on some BALLARD ACCESS Closed Suction Systems may cause inadequate ventilation or other injury to vulnerable patients. Tue, 02 May 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-inc-recalls-certain-ballard-access-closed-suction-systems-neonatespediatrics-risk