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Single Use Sphincterotome V(Distal Wireguided) recallZ-1280-2026 · Olympus Corporation of the Americas · initiated Jan 7, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 [email protected] or by phone at (647) 999-3203.

Recall details

Recall number
Z-1280-2026
Status
Open, Classified
Initiated by the company
Jan 7, 2026
Posted by the FDA
Feb 5, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
5946 units (2208 US, 3738 OUS)
Product code
KNS
FDA submissions
K250945
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.

Product description

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; 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 (models, lots, serial numbers)

Model/Catalog Number: KD-VC411Q-0320; Material REF: (1) N5391030, (2) N5391010, (3) N5777330; UDI-DI: (1) 04953170466403, (2) 04953170466403, (3) 04953170466403; All Lots with a valid expiration date

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98252).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page