Recall Z-1287-2026 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus Corporation of the Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
| Date | Feb 5, 2026 (initiated Jan 7, 2026) |
| Status | Open, Classified |
| Reason | Devices which did not undergo thermoforming could deform and lose performance. |
| Root 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 lett |
| Quantity | 886 units (OUS only) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950166 | OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE Olympus America, Inc., Feb 22, 1995 |