Class 2 Device Recall CleverCut

• Date Initiated by Firm: January 07, 2026
• Date Posted: February 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1283-2026
• Recall Event ID: 98252
• 510(K)Number: K250945
• Product Classification: Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
• Product: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-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.
• Code Information: Model/Catalog Number: KD-VC433Q-0720; Material REF: (1) N5391710, (2) N5391730, (3) N5778030; UDI-DI: (1) 04953170371219, (2) 04953170371219, (3) 04953170371219; All Lots with a valid expiration date
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-9993203
• Manufacturer Reason for Recall: Devices which did not undergo thermoforming could deform and lose performance.
• FDA Determined Cause: Process control
• Action: On or around January 7, 2026, URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: the following actions: 1. Examine your inventory and quarantine any identified devices immediately. 2. Immediately cease usage of any affected product in your inventory. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your affected product. 4. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0487 c. Complete the form as instructed. 5. If you have further distributed it, please forward this notice to other users who may have the affected products. Olympus requests you to report any complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@olympus.com or by phone at (647) 999-3203.
• Quantity in Commerce: 1504 units (350 US, 1154 OUS)
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KNS