Recall Z-0570-2026— Olympus Corporation of the Americas
Class I · Ongoing
Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-10-30
- Firm location
- Center Valley, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.