# FDA recall Z-0482-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-10-06.

## Product

Brand Name: Olympus Single Use Electrosurgical Snare SD-400  Product Name: Single Use Electrosurgical Snare  Model/Catalog Number: SD-400U-10  Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

## Reason for recall

Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.

## Distribution

Worldwide distribution - US Nationwide and the countries of GU, and MP.

## Key facts

- **Recall number:** Z-0482-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-06
- **Report date:** 2025-11-19

- **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-0482-2026

## Citation

> AI Analytics. FDA recall Z-0482-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0482-2026. Source: US FDA. Licensed CC0.

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