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 3
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
These labels are deterministic app interpretations, not FDA categories.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Code information
Model No. ADVC800-03; UDI: 10809160450703; Lot Code: 1640852; Exp: 2/4/2028.
Distribution pattern
US Nationwide distribution in the states of IL & LA.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
These labels are deterministic app interpretations, not FDA categories.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Code information
Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.
Distribution pattern
US Nationwide distribution in the states of IL & LA.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
These labels are deterministic app interpretations, not FDA categories.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Code information
Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.
Distribution pattern
US Nationwide distribution in the states of IL & LA.
