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.
An incorrect sizing label was applied to the carton packaging.
Code information
Lot numbers 1728375 and 1728376, UDI #00840420121707.
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.