96 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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