[pending] Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgica
Pending LLM rewrite. Source: FDA_DEVICE Z-1223-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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 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
- 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: 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
Distribution
Distributed nationwide across the United States.
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