FDA recall, , Moderate risk
Olympus Single Use Electrosurgical Knives KD-640L and KD-645
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, of Center Valley, Pennsylvania, began a recall of its Olympus Single Use Electrosurgical Knife KD-640L and KD-645L on February 17, 2024.
The devices are electrosurgical devices 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 surgery. The recall was added to the FDA's Enforcement Report on January 30, 2026, with distribution nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus Single Use Electrosurgical Knife KD-640L
- UDI-DI
- 04953170208423
- Model/Catalog number
- KD640-L
- Lot code
- 2ZK
- 31K
- 32K
- 33K
- 34K
- 35K
- 36K
- 37K
- 38K
- 39K
- 3XK
- 3YK
- 3ZK
- 41K
- 42K
- 43K
- 44K
- 45K
- 46K
- 47K
- 48K
- 49K
- 4XK
- 4YK
- 4ZK
- 51K
- 52K
- 53K
- 54K
- 55K
- 58K
- 59K
Olympus Single Use Electrosurgical Knife KD-645
- UDI-DI
- 04953170407857
- Model/Catalog number
- KD-645L
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98007
- Recall numbers
- Z-1222-2026 to Z-1223-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
