Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30
- Recalling company
- Olympus Corporation of the Americas
- 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 – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Oct 30, 2025
- Reported
- Dec 3, 2025
- Distribution
- US-wide distribution
- Status
- Ongoing
- Quantity
- 7803 units
- Lot / codes
- Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0570-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0570-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.