MedWatch Safety Alerts RSS Feed http://www.fda.gov/ en 2023 Safety Communications 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 Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication 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 Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitroso-dabigatran (NDAB) Impurity 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 UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication 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 Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure 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 2023 Medical Device Recalls 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 Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When Connected with an Oxygen Concentrator 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 Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication 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 Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers 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 Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers 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 2023 Letters to Health Care Providers 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 All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication - FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information  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 Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility 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 Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles 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 Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers 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 UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication 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 ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA 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 Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers 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 Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination 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 Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers 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