BEUDAMED
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    Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code LQR·March 5, 2026

    Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·January 8, 2009

    Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3515. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·January 8, 2009

    Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·January 8, 2009

    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code LQR·March 5, 2026

    SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code DZD·January 17, 2020

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·January 14, 2020

    MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).

    FDA Recall
    Open, Classified ·Avanos Medical, Inc.·Product code KNT·May 31, 2024

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021