Recall Z-1223-2026 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus Corporation of the Americas
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L 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 durin
| 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 | 3361 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 Olympus Medical Systems Corp., May 15, 2019 |