# FDA recall Z-2541-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-07-01.

## Product

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps.  Coagulation is achieved using electrosurgical energy under visualization.  The device is to be used with bipolar outputs of compatible generators.  The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.  To transect tissue, a cutting blade is actuated and moves between the electrode jaws.        The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005).  The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps.  The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue.  The anatomical structure to be co

## Reason for recall

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

## Distribution

Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

## Key facts

- **Recall number:** Z-2541-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-01
- **Report date:** 2024-08-14

- **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-2541-2024

## Citation

> AI Analytics. FDA recall Z-2541-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2541-2024. Source: US FDA. Licensed CC0.

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