# FDA recall Z-0570-2026

> **Olympus Corporation of the Americas** · Class I · device recall initiated 2025-10-30.

## Product

Brand Name: Single Use Ligating Device  Product Name: Olympus HX-400U-30  Model/Catalog Number: HX-400U-30  Used with an Olympus endoscope to deliver a nylon loop snare.

## Reason for recall

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

## Distribution

US-wide distribution

## Key facts

- **Recall number:** Z-0570-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-30
- **Report date:** 2025-12-03

- **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-0570-2026

## Citation

> AI Analytics. FDA recall Z-0570-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0570-2026. Source: US FDA. Licensed CC0.

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