openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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;
