# FDA recall Z-1548-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-03-01.

## Product

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract  Model: KD-645L

## Reason for recall

Due to increase in complaints for the  KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1548-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-01
- **Report date:** 2024-09-18

- **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-1548-2024

## Citation

> AI Analytics. FDA recall Z-1548-2024. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1548-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*