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.
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
These labels are deterministic app interpretations, not FDA categories.
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Code information
Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.
