Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife
Pending LLM rewrite. Source: FDA_DEVICE Z-1222-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
The recalled product
- Product
- 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 electr
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Catalog Number: KD640-L UDI: 04953170208423 Lot Number(s): 2ZK
- 31K
- 32K
- 33K
- 34K
- 35K
- 36K
- 37K
- 38K
- 39K
- 3XK
- 3YK
- 3ZK
- 41K
- 42K
- 43K
- 44K
- 45K
- 46K
- 47K
Distribution
Distributed nationwide across the United States.
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