Olympus Corporation of the Americas: Device Recall

Recall #Z-1269-2026 · 01/07/2026

Class II: Risk

Recall Details

Recall Number: Z-1269-2026
Classification: Class II
Product Type: Device
Recalling Firm: Olympus Corporation of the Americas
Status: Ongoing
Date Initiated: 01/07/2026
Location: Center Valley, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12641 units (8789 US, 3852 OUS)

Reason for Recall

Devices which did not undergo thermoforming could deform and lose performance.

Product Description

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.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

Other Recalls by Olympus Corporation of the Americas

Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.