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 Endos
Recall Summary Olympus Corporation of the Americas is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-0720) used during endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and not work as intended. The recall affects these surgical 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-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.
- 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/b3b5d086-4ed9-4f1a-a4a1-f241cd3e8a65