Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalo
FDA device recall Z-1222-2026 · posted 2026-01-30 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- Action taken
- 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 notification to them. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KNS
- Quantity affected
- units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-02-17
- Date posted
- 2026-01-30
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L (K092309) | Olympus Medical Systems Corporation | 2009-10-30 |