69 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·March 31, 2022
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FBN·December 20, 2017
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FBN·September 25, 2023
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FBN·December 18, 2024
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·August 31, 2020
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FBN·April 6, 2016
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·December 12, 2016
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FBN·April 6, 2016
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
FDA Recall
Open, Classified
·TANGENT ENDOSCOPY, LLC·Product code FBN·March 23, 2026
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
FDA Recall
Terminated
·Galt Medical Corporation·Product code DYB·May 2, 2018
Medicina Oral Tip Syringe 2.5ml Code: OT25
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina Reusable Oral syringe 5ml Code: OTH05
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina Oral Tip Syringe 1ml Code: OT01
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina Reusable Oral syringe 1ml Code: OTH01
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina Reusable Oral syringe 2.5ml Code: OTH25
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
Medicina Oral Tip Syringe 0.5ml Code: OT005
FDA Recall
Open, Classified
·Medicina Uk Ltd·Product code KYW·July 4, 2022
smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code OMP·January 29, 2010
***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code OMP·December 14, 2010