BEUDAMED
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    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·September 9, 2015

    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    FDA Recall
    Terminated ·Halyard Health, Inc·Product code BSY·July 29, 2015

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·January 8, 2016

    EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·March 15, 2016

    Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FDT·March 16, 2021

    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code FDT·March 26, 2015

    Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDT·April 21, 2021

    Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDT·April 6, 2016

    Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDT·January 17, 2017

    Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·March 9, 2015

    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·January 28, 2021

    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·June 30, 2015

    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·December 23, 2015

    Video Duodenoscope

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDT·February 22, 2016

    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·August 31, 2015

    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDT·February 13, 2018