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.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Code information
All lots Catalog numbers J-RSN-901600 and 090002
Distribution pattern
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Code information
All lots Catalog numbers J-PLC-751810 and 090100
Distribution pattern
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Code information
All lots Catalog numbers: 095000; 095015; 095030; J-SYN-931600; J-SYN-931615; J-SYN-931630
Distribution pattern
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Code information
All lots Catalog numbers: J-CRKP-042900
Distribution pattern
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Code information
All lots Catalog numbers: J-EIE-051500
Distribution pattern
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
