96 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·February 17, 2024
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
JAGTOME RX 39-20-450-025 Material Number: M00573090
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
DREAMTOME 44-30MM/260CM Material Number: M00584050
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 19, 2025
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
HYDRATOME RX 44-30MM/260CM Material Number: M00583050
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
JAGTOME RX 39-30-450-025 Material Number: M00573110
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
DREAMTOME 44-30MM/450CM Material Number: M00584070
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 19, 2025
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code KNS·January 7, 2026
JAGTOME RX 49-30-450-035 Material Number: M00573030
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021