Olympus Corporation of the Americas: Device Recall

Recall #Z-0570-2026 · 10/30/2025

Class I: Dangerous

Recall Details

Recall Number
Z-0570-2026
Classification
Class I
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
10/30/2025
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7803 units

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.

Product Description

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.

Distribution Pattern

US-wide distribution

Other Recalls by Olympus Corporation of the Americas

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.