Recall Z-1222-2026 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus Corporation of the Americas
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endo
| Date | Jan 30, 2026 (initiated Feb 17, 2024) |
| Status | Open, Classified |
| Reason | A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. |
| Root cause | Device Design |
| Action | On December 17, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Carefully read the content of this notification. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the instruction for intermittent output activation and applicable Warnings and Cautions. 3. Keep a copy of this notification with the Instructions for Use for any affected devices remaining in your inventory. 4. If you have further distributed the affected product, please identify your customers and forward this |
| Quantity | units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092309 | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L Olympus Medical Systems Corporation, Oct 30, 2009 |