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 7
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 10193489191349 (ea) 20193489191346 (case); Lot 2023052490
Distribution pattern
US Nationwide distribution.
device · product 3 of 7
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 00653160196894 (ea) 30653160196895 (case); Lot 2023091290
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 00653160007671 (ea) 50653160007676 (case); Lot 2023012390
Distribution pattern
US Nationwide distribution.
device · product 5 of 7
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 10653160382140 (ea) 00653160382143 (case); Lot 2023012490
Distribution pattern
US Nationwide distribution.
device · product 6 of 7
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 10653160327141 (ea) 00653160327144 (case); Lot 2023021390
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information
UDI: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490
