---
title: "Olympus: Single use ligating device — FDA announcement Dec 18, 2025 | Is It on Recall"
description: "PolyLoop device may fail to detach as expected and become anchored to patient anatomy"
url: https://isitonrecall.com/recall/fdapress-8d1e98722e4d0091-olympus-single-use-ligating-device/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Olympus: Single use ligating device — FDA announcement Dec 18, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Dec 18, 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**: Single use ligating device
- **Reason**: PolyLoop device may fail to detach as expected and become anchored to patient anatomy
- **Classification**: Not supplied
- **Recalling firm**: Olympus Corporation
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: 8d1e98722e4d0091

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-announces-voluntary-corrective-action-single-use-ligating-device)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Not supplied |

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

## Distribution

Not supplied

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

## Dates in the source

- **Fda listing date**: Dec 18, 2025
- **Company announcement date**: Dec 5, 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://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-announces-voluntary-corrective-action-single-use-ligating-device)

## Related records

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