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 G
Recall Summary Olympus is recalling Single Use Sphincterotome V devices (Model KD-VC431Q-0720) 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. The affected devices were designed to be used with Olympus endoscopes and guidewires to perform papillotomy procedures using high-frequency electrical current. This is classified as a Class II recall issued by Olympus Corporation of the Americas.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- 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.
- 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/46084c4a-6727-4d1b-9a37-29727ec5a84b