39 results
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7ms
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Sources: EU EUDAMED, US FDA
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
FDA Enforcement
Class II
·Ongoing·Copan Italia·June 18, 2025
VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·March 12, 2025
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 8, 2026
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024