Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgica
Pending LLM rewrite. Source: FDA_DEVICE Z-1223-2026.
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 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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22