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.
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Code information
UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Code information
UDI/DI Case 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Code information
UDI/DI Case 40195327231126, UDI/DI Each 10195327231125; Lot Numbers: 22LBM357
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Code information
UDI/DI Case 40195327334209, UDI/DI Each 10195327334208; Lot Numbers: 23IBJ309, 23GBA500, 23GBA457, 23CBE394, 23BBL312
