105 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code DXT·September 26, 2023
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·June 12, 2024
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-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: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-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
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·February 2, 2023
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 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
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code KNS·December 18, 2025
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
DREAMTOME 49-20MM/260CM Material Number: M00584000
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
HYDRATOME RX 44-30MM/450CM Material Number: M00583070
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
JAGTOME RX 49-30-260-035 Material Number: M00573020
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 20, 2024
JAGTOME RX 44-20-260-035 Material Number: M00573040
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·December 22, 2021
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNS·August 26, 2022