http://www.fda.gov/ en http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Fri, 01 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/medical-devices/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. The device may stop unexpectedly due to Autofill Failure Alarms and will be put in standby mode. Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps http://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps Datascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for unexpected electrical shutdowns. Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-all-products-manufactured-between-march-2021-and On July 1, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i.The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-all-products-manufactured-between-march-2021-and http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Thu, 31 Aug 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/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-power Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. If they become unseated from the hospital cart, they can shut down without warning. Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-power http://www.fda.gov/medical-devices/letters-health-care-providers/getinge-maquetdatascope-intra-aortic-balloon-pump-iabp-shortage-letter-health-care-providers The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts. Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/getinge-maquetdatascope-intra-aortic-balloon-pump-iabp-shortage-letter-health-care-providers http://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-pcba Datascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA failures affecting the ability to charge the batteries Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-pcba http://www.fda.gov/medical-devices/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-gas The Cardiosave IABP may stop unexpectedly due to a high priority Gas Gain or Gas Loss alarm. The alarm will interrupt therapy and require user intervention to correct and restart. Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-gas http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP, Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin http://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-device-failures-getinges-maquetdatascope-cardiosave-intra-aortic-balloon-pump-iabp Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops). Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-device-failures-getinges-maquetdatascope-cardiosave-intra-aortic-balloon-pump-iabp 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. Thu, 31 Aug 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/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-system The Cardiosave IABP may stop unexpectedly when internal temperatures exceed 176 degrees Fahrenheit. Thu, 31 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/getingemaquetdatascope-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-system http://www.fda.gov/medical-devices/medical-device-recalls/hamilton-medical-inc-recalls-hamilton-c1-c2-c3-t1-ventilators-software-issues-may-cause-ventilators Hamilton Medical Inc. recalls HAMILTON-C1, C2, C3, T1 Ventilators for software issues that may cause ventilators to stop without notice after approximately 91 days of cumulative use. Wed, 30 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/hamilton-medical-inc-recalls-hamilton-c1-c2-c3-t1-ventilators-software-issues-may-cause-ventilators http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-bernes-whole-health-products-issues-voluntary-nationwide-recall-dr-bernes-msm-drops-5-and-15 Tesuque, NM, Dr. Berne’s Whole Health Products is voluntarily recalling all lots of MSM DROPS 5%,15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution to the consumer level. Sat, 26 Aug 2023 11:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-bernes-whole-health-products-issues-voluntary-nationwide-recall-dr-bernes-msm-drops-5-and-15 http://www.fda.gov/medical-devices/medical-device-recalls/draeger-recalls-carina-sub-acute-care-ventilators-contaminants-airpath Contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. Wed, 23 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/draeger-recalls-carina-sub-acute-care-ventilators-contaminants-airpath http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/inmar-supply-chain-solutions-llc-issues-voluntary-recall-product-stored-its-arlington-texas-facility Inmar Supply Chain Solutions, LLC (“Inmar”), is voluntarily recalling FDA regulated products* contained in pallets stored in Inmar’s Arlington, Texas facility between May 1, 2022, and June 30, 2023, the (“FDA Recalled Products”). The FDA Recalled Products were stored in this facility during a time Wed, 23 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/inmar-supply-chain-solutions-llc-issues-voluntary-recall-product-stored-its-arlington-texas-facility 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, 17 Aug 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/abiomed-recalls-labeling-impella-rp-flex-smartassist-risk-blood-clots Abiomed recalls labeling for the Impella RP Flex with SmartAssist. The pump supports circulation of blood to the right heart and may cause blood clots. Thu, 17 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-labeling-impella-rp-flex-smartassist-risk-blood-clots http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-trilogy-evo-evo-o2-ev300-and-evo-universal-ventilators-after-finding Philips Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide breathing support, but dust and dirt in the air path may impact air flow to patients. Mon, 14 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-trilogy-evo-evo-o2-ev300-and-evo-universal-ventilators-after-finding