Electrosurgical knife KD-645 recalled over tip breakage during use
Olympus is recalling 3,361 Single Use Electrosurgical Knife KD-645 units 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-645, model/catalog number KD-645L, is being recalled by Olympus Corporation of the Americas. The record describes it as an electrosurgical device consisting of a handpiece and a monopolar electrode.
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 lists 3,361 units under UDI 04953170407857, 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 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
- Affected units
- 3,361
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.
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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