FDAHealthOctober 30, 2025
Olympus Corporation of the Americas — 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
⚠️ 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- October 30, 2025
US-wide distribution
What's affected?
- 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.
- Lot code
- which
Additional details
Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 7803 units.
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