Product Name: Single Use 3-lumen Sphincterotome V Model/catalog Number: Kd-v411m-0330; Software Version: N/a Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endos
Recall Summary Olympus Corporation of the Americas is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-0330) used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform or fail to work as intended. This is a Class II recall affecting medical instruments designed for use with Olympus endoscopes.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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.
- Reason
- Devices which did not undergo thermoforming could deform and lose performance.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8b85d671-fcc7-4aba-9ea0-80002868b0f0