BEUDAMED
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    IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CFF·January 28, 2004

    Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Recall
    Open, Classified ·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code JKA·September 26, 2025

    QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·July 30, 2011

    Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;

    FDA Recall
    Terminated ·Therakos Inc·Product code LNR·March 29, 2010

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    FDA Recall
    Terminated ·OrthoPediatrics Corp·Product code HWC·July 24, 2013

    InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FGS·September 29, 2010

    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code KFF·July 21, 2025

    Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

    FDA Recall
    Terminated ·Cook OB/Gyn, Inc.·Product code HFE·April 2, 2009

    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    HemosIL LMW Heparin Controls; Part Number: 0020300200;

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2025

    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.

    FDA Recall
    Terminated ·International Technidyne Corp.·Product code KFF·June 24, 2010

    Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code KFF·June 7, 2004

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·August 25, 2021

    Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.

    FDA Recall
    Open, Classified ·Aesculap Inc·Product code KAE·January 31, 2025

    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·December 18, 2024

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code KFF·July 18, 2014

    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023