---
title: "Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model... — FDA record Z-0570-2026 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0570-2026-brand-name-single-use-ligating-device-product-name-olympus-hx-400u-30-model-catalog-number-hx-400u-3/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an... — FDA record Z-0570-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class I
- **Recalling firm**: Olympus Corporation of the Americas
- **Quantity**: 7803 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0570-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0570-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US-wide distribution

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 3, 2025
- **Recall initiation date**: Oct 30, 2025
- **Center classification date**: Nov 25, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0570-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Olympus Corporation of the Americas records](https://isitonrecall.com/brand/olympus-corporation-of-the-americas/)