Recall Z-0570-2026 ยท MND Ligator, Esophageal
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 snare.
| Date | Nov 25, 2025 (initiated Oct 30, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On October 30, 2025 and again on November 3, 2025, URGENT: MEDICAL DEVICE CORRECTIVE ACTION letters were sent to customers. Actions to be taken: Users are reminded of the importance of adhering to the Warnings and Cautions statements that are present in the instructions for use (IFU, ref: GK4574 Rev 16). A diagram was provided to illustrate the need to maintain a straight position of the proximal end of the tube sheath to prevent increased frictional resistance which may lead to breakage of the operating piipe when the slider is pushed. Particular attention should be paid to the following key |
| Quantity | 7803 units |
| Distribution | US-wide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.