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Recall Observatory FDA recall evidence

Device 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.

Z-0570-2026

October 30, 2025

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 97731
Status
Ongoing
Classification
Class I
Quantity
7803 units
Official record key
device-enforcement:Z-0570-2026

Official wording

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.

Code information: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;

Distribution pattern: US-wide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.