# FDA recall Z-1222-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-02-17.

## 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 electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1222-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-17
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2026

## Citation

> AI Analytics. FDA recall Z-1222-2026. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1222-2026. Source: US FDA. Licensed CC0.

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