Z-0570-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7803 units
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.
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 Pattern
US-wide distribution
Code Information
Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;