FDA recall Z-0570-2026

Olympus Corporation of the Americas · Class I · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2026