http://www.fda.gov/ en http://www.fda.gov/medical-devices/safety-communications/update-recommendations-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric-face Certain surgical respirators, surgical masks, and pediatric face masks by O&amp;M Halyard do not meet quality and performance expectations. Fri, 29 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-recommendations-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric-face http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Fri, 29 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scynexis-issues-voluntary-nationwide-recall-brexafemmer-ibrexafungerp-tablets-due-potential-cross SCYNEXIS, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a nonantibacterial<br /> ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tab Thu, 28 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scynexis-issues-voluntary-nationwide-recall-brexafemmer-ibrexafungerp-tablets-due-potential-cross http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-expands-nationwide-recall-all-products-manufactured-between-march-2021-and 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 these distributed Fri, 22 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-expands-nationwide-recall-all-products-manufactured-between-march-2021-and 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. Fri, 22 Sep 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/vistapharm-llc-issues-voluntary-nationwide-recall-sucralfate-oral-suspension-1g10ml-due-microbial September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. Fri, 22 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vistapharm-llc-issues-voluntary-nationwide-recall-sucralfate-oral-suspension-1g10ml-due-microbial http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Wed, 20 Sep 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/medline-industries-recalls-hudson-rci-addipak-unit-dose-vial-09-full-normal-saline-solution-due Medline Industries recalled Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, which is used for inhalation and irrigation therapy. The saline solution was found to be non-sterile. Wed, 20 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medline-industries-recalls-hudson-rci-addipak-unit-dose-vial-09-full-normal-saline-solution-due http://www.fda.gov/medical-devices/medical-device-recalls/abbott-medical-recalls-proclaim-and-infinity-ipgs-inability-exit-magnetic-resonance-imaging-mri-mode The Abbott Proclaim and Infinity neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The device may be unable to exit MRI mode and resume therapy. Wed, 13 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abbott-medical-recalls-proclaim-and-infinity-ipgs-inability-exit-magnetic-resonance-imaging-mri-mode http://www.fda.gov/safety/medical-product-safety-information/bone-matrix-product-fda-safety-communication-important-information-human-cell-tissue-and-cellular FDA is working closely with the CDC to investigate recent reports of a TB outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product. Tue, 12 Sep 2023 14:00:00 EDT FDA http://www.fda.gov/safety/medical-product-safety-information/bone-matrix-product-fda-safety-communication-important-information-human-cell-tissue-and-cellular http://www.fda.gov/medical-devices/medical-device-recalls/mallinckrodt-manufacturing-llc-recalls-one-way-valve-22f-x-22m-not-opening-properly The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways. Tue, 12 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/mallinckrodt-manufacturing-llc-recalls-one-way-valve-22f-x-22m-not-opening-properly 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. Mon, 11 Sep 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/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for Mon, 11 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/church-dwight-issues-voluntary-nationwide-recall-one-specific-lot-therabreath-strawberry-splash-kids FOR IMMEDIATE RELEASE – September 13, 2023 – EWING, N.J – Church &amp; Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz after the Company identified a microbial contamination due to the presence of yeast (Candida Parapsilo Fri, 08 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/church-dwight-issues-voluntary-nationwide-recall-one-specific-lot-therabreath-strawberry-splash-kids http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hua-da-trading-inc-dba-wefun-inc-issues-voluntary-nationwide-recall-wefun-capsules-due-presence Brooklyn, New York, WEFUN Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the trea Tue, 05 Sep 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hua-da-trading-inc-dba-wefun-inc-issues-voluntary-nationwide-recall-wefun-capsules-due-presence 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/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/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