[pending] Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife
Pending LLM rewrite. Source: FDA_DEVICE Z-1222-2026.
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 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.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27