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Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

Medical Device Recalls - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

    Recalls Related to the HVAD System | FDA

      https://www.fda.gov/medical-devices/cardiovascular-devices/recalls-related-hvad-system
      Since the HVAD System's approval in 2012, the agency has continued to monitor the product's safety and effectiveness by reviewing medical literature, clinical …

    Smiths Medical Recalls Certain CADD System …

      https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-cadd-system-administration-sets-and-cassette-reservoirs-issues
      Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy …

    Datascope/Getinge Recalls Cardiosave Hybrid and …

      https://www.fda.gov/medical-devices/medical-device-recalls/datascopegetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk-blood-may
      Devices Recalled in the U.S.: 4,454 Date Initiated by Firm: December 19, 2022 Device Use The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the …

    Medical Device Recalls - Food and Drug Administration

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=114595
      November 19, 2012: Create Date: December 14, 2012: Recall Status 1: Terminated 3: Recall Number: Z-0514-2013: Recall Event ID: 63710: Product: Patient …

    Medical device recalls for September 2012 - MassDevice

      https://www.massdevice.com/medical-device-recalls-september-2012/
      The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 – degenerative disc disease; 2 – spondylolisthesis; 3 – …

    2023 Medical Device Recalls | FDA

      https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls
      2023 Medical Device Recalls | FDA An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search Menu …

    Universal Meditech Inc. Recalls Skippack Medical Lab …

      https://www.fda.gov/medical-devices/medical-device-recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not
      Recalled Product Product Names: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) Product Code: QKP Distribution Dates: January 2022 …

    LivaNova (TandemLife) Recalls LifeSPARC for Pump …

      https://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-recalls-lifesparc-system-risk-unintentional-extended-pump-stop-during-controller
      On July 21, 2022, LivaNova (TandemLife) sent customers an Urgent Medical Device Communication. The letter recommended the following immediate actions: For …



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