Reported Feb 11, 2026 · Ongoing

Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L…

Olympus Corporation of the Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229

Is this the product you have?

  • Brand NameSingle
  • Use Electrosurgical Knife Product NameOlympus Single Use Electrosurgical
  • Knife KD-640L Model/Catalog NumberKD640-L
  • Product DescriptionAn 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/ablation during endoscopic (including laparoscopic, arthroscopic) surgery
Lot codes and dates
  • Model/Catalog NumberKD640-L
  • UDI04953170208423
  • Lot Number(s)
    • 2ZK
    • 31K
    • 32K
    • 33K
    • 34K
    • 35K
    • 36K
    • 37K
    • 38K
    • 39K
    • 3XK
    • 3YK
    • 3ZK
    • 41K
    • 42K
    • 43K
    • 44K
    • 45K
    • 46K
    • 47K
    • 48K
    • 49K
    • 4XK
    • 4YK
    • 4ZK
    • 51K
    • 52K
    • 53K
    • 54K
    • 55K
    • 58K
    • 59K
Amount recalled
units

This recall covers 32 products

The agency filed one notice per product. You are reading one of them; the other 31 are below.

19 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.