Electrosurgical knives recalled over tip breakage from overheating and burning
Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states overheating and burning can contribute to tip breakage during use, and no injuries are reported.
Plain-English summary
The Olympus Single Use Electrosurgical Knife KD-640L, model/catalog number KD640-L, is being recalled by Olympus Corporation of the Americas. The record describes it as an electrosurgical device 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 or ablation.
The reason given in the enforcement record is that a deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
The record's quantity field reads only 'units', so no count is given here. The recall covers UDI 04953170208423 with lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
A tip that breaks during use is a risk to the patient. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Olympus' instructions.
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…
- Manufacturer
- Olympus Corporation of the Americas
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.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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