HIGH

Olympus Recalls Electrosurgical Knife Over Burn Hazard

Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.

Quick Facts at a Glance

Recall Date
February 17, 2024
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the Olympus Single Use Electrosurgical Knife, model KD-645L. It consists of a handpiece and monopolar electrode designed for surgical procedures. The product was distributed across the United States.

The Hazard

The electrosurgical knife may overheat and burn, leading to potential tip breakage during surgical procedures. This poses a significant burn risk to patients and healthcare providers.

Reported Incidents

There have been no specific reported injuries or incidents related to this recall. However, the potential for burns and injury exists if the device is used.

What to Do

Stop using the affected electrosurgical knife immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.

Contact Information

For more information, contact Olympus Corporation of the Americas at their official website or through the recall notification letter.

Key Facts

  • Recall date: February 17, 2024
  • 3371 units recalled
  • Model number: KD-645L
  • Potential burn and tip breakage risks
  • Distributed nationwide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Classification

Product Details

Model Numbers
Model/Catalog Number: KD-645L UDI: 04953170407857 Lot Number(s): 2ZK
31K
32K
33K
35K
+15 more
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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