BEUDAMED
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    AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    FDA Recall
    Terminated ·ESAOTE S.P.A Via Enrico Melen·Product code IYN·September 8, 2020

    SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·September 24, 2019

    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·March 21, 2013

    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·March 21, 2013

    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

    FDA Recall
    Terminated ·Dignitana, Inc.·Product code PMC·November 5, 2021

    Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.

    FDA Recall
    Terminated ·Kerr Corporation·Product code EMA·March 3, 2011

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·January 15, 2015

    AIA-360 Automated Immunoassay Analyzer, Product Code 019945

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·January 10, 2020

    HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·December 23, 2004

    Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed

    FDA Recall
    Terminated ·Linet Americas Inc·Product code FNK·May 2, 2011

    ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code NEP·June 22, 2022

    Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

    FDA Recall
    Terminated ·Cook Ireland Ltd. O'holloran Road, National Technological Park Limerick, Peroc Ireland·Product code NIO·January 5, 2012

    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 25, 2015

    VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·July 12, 2017

    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 25, 2015

    Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 25, 2015

    VITEK2 GP-ID, REF 21342 IVD

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LQL·October 11, 2017