72 results
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27ms
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Sources: EU EUDAMED, US FDA
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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 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
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code FDT·March 3, 2022
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code FDT·September 27, 2023
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·October 14, 2025
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
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code FDT·March 3, 2022
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
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code FDT·March 3, 2022
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code FDT·March 3, 2022
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
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·November 2, 2021
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·July 27, 2023
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·December 8, 2023