BEUDAMED
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    Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MUE·October 24, 2025

    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·July 15, 2022

    EVair air compressor, model numbers: M1230849 and M1230847

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FGE·October 21, 2021

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023

    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGE·November 10, 2023

    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·May 15, 2024

    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    Freeman Pancreatic Flexi-Stent Catalog Number: 6535

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023

    Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·March 1, 2024

    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGE·November 10, 2023

    EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGE·November 10, 2023

    Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    Freeman Pancreatic Flexi-Stent Catalog Number: 6567

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023