96 results · 13ms · Sources: EU EUDAMED, US FDA

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HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L 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: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 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: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 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 (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; 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

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 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 39-20-260-025 Material Number: M00573080

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

JAGTOME RX 44-20-450-035 Material Number: M00573050

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

DREAMTOME 49-20MM/450CM Material Number: M00584020

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

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-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 (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; 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

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 19, 2025

AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024