# FDA recall Z-1638-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-02-25.

## Product

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm  Product Name: Everest Bipolar Cutting Forceps  Model/Catalog Number: 3005  Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

## Reason for recall

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

## Distribution

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

## Key facts

- **Recall number:** Z-1638-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-25
- **Report date:** 2026-04-01

- **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-1638-2026

## Citation

> AI Analytics. FDA recall Z-1638-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1638-2026. Source: US FDA. Licensed CC0.

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