Olympus Corporation Of The Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-072…

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

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1288-2026
• FDA 510(k) clearance · K950166The device's official FDA premarket clearance record
• FDA device classification · KNSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.