BEUDAMED
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    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·May 9, 2019

    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

    FDA Recall
    Open, Classified ·Fisher Diagnostics·Product code GJS·March 6, 2025

    HemosIL ReadiPlasTin, Part No. 0020301400

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code GJS·April 8, 2022

    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code FJS·February 15, 2023

    Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

    FDA Recall
    Open, Classified ·Fisher Diagnostics·Product code GJS·March 6, 2025

    a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code GJS·May 25, 2022

    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code GJS·October 13, 2021

    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

    FDA Recall
    Open, Classified ·Brasseler USA I Lp·Product code EJL·January 11, 2024

    Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.

    FDA Recall
    Open, Classified ·Medtronic Inc·Product code LOX·June 24, 2022

    AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code IZZ·May 31, 2024

    AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code IZZ·May 31, 2024

    ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code IZZ·May 31, 2024

    Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·January 16, 2026

    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

    FDA Recall
    Open, Classified ·LeMaitre Vascular, Inc.·Product code DXE·September 30, 2022

    Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·January 29, 2026

    Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·January 29, 2026

    The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·May 17, 2024

    The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·May 31, 2024

    Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    FDA Recall
    Open, Classified ·Covidien Llc·Product code GCI·May 12, 2020

    Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    FDA Recall
    Open, Classified ·Covidien Llc·Product code GCI·May 12, 2020