http://www.fda.gov/ en http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Thu, 23 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication Many Exactech knee, ankle, and hip replacement devices were packaged in defective bags and may fail. Thu, 23 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratorie Wed, 22 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg http://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication The FDA updates information on reports of squamous cell carcinoma in the capsule around breast implants. Wed, 22 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/datascopegetinge-recalls-certain-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk The coiled cord on some Cardiosave IABPs may fail and cause an unexpected shutdown, interrupting therapy to the patient with no warning. Fri, 17 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/datascopegetinge-recalls-certain-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Fri, 17 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-life2000-ventilation-system-due-potential-patient Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events... Fri, 10 Mar 2023 14:45:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-life2000-ventilation-system-due-potential-patient http://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda Reports of squamous cell carcinoma and various lymphomas in capsule around breast implants. Read recommendations for patients and health care providers Wed, 08 Mar 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda http://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-risk-exposure-toxic-compounds-when-using-hemodialysis-and-peritoneal-dialysis The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems Tue, 07 Mar 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-risk-exposure-toxic-compounds-when-using-hemodialysis-and-peritoneal-dialysis http://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines Tue, 07 Mar 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured 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. Tue, 07 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/safety/medical-product-safety-information/all-allergenic-extracts-diagnosis-food-allergy-fda-safety-communication-fda-requires-warning-about FDA determined that the risk of anaphylaxis following false negative food allergen skin test results is applicable to all allergenic extracts for the diagnosis of food allergies. Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in Prescribing Information. Fri, 03 Mar 2023 17:45:00 EST FDA http://www.fda.gov/safety/medical-product-safety-information/all-allergenic-extracts-diagnosis-food-allergy-fda-safety-communication-fda-requires-warning-about http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility. Fri, 03 Mar 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the u Thu, 02 Mar 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due 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/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