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 2
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Code information
UDI-DI:10889942848447; Lot Number: 24EBP466
Distribution pattern
US Nationwide distribution in the state of TN.
device · product 2 of 2
ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Code information
UDI-DI: 10195327246747; Lot Numbers: 24GBI464 24HBO800
