Brand Name: Single Use Electrosurgical Knife KD-645 recallZ-1223-2026 · Olympus Corporation of the Americas · initiated Feb 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
FDA root cause category: Device Design
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1223-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 17, 2024
- Posted by the FDA
- Jan 30, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 3361 units
- Product code
- KNS
- FDA submissions
- K182408
- Distribution
- US Nationwide distribution.
Product description
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 during endoscopic (including laparoscopic, arthroscopic) surgery.
Code information (models, lots, serial numbers)
Model/Catalog Number: KD-645L UDI: 04953170407857 Lot Number(s): 2ZK, 31K, 32K, 33K, 35K, 3XK, 3YK, 3ZK, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 56K, 57K, 58K, 59K
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Single Use Electrosurgical Knife KD-645 KD-645LOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)2 recalls26 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98007).
- Z-1222-2026 · Open, ClassifiedBrand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical de…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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