Product Name: Single Use 3-lumen Sphincterotome V Model/catalog Number: Kd-v411m-3025 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For P
Recall Summary Olympus is recalling Single Use 3-Lumen Sphincterotome V medical devices (Model KD-V411M-3025) used during endoscopic procedures because some units may not have been properly heat-formed during manufacturing, which could cause them to deform and not work as intended. These devices are designed to be used with Olympus endoscopes for a specific biliary procedure. The recall affects devices distributed by Olympus Corporation of the Americas.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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/6362e508-6615-44a7-9b9a-32e8d1257a7c