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
Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
These labels are deterministic app interpretations, not FDA categories.
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
Code information
UPC: (01) 20885380116008 Lot: 20180717A1
Distribution pattern
US nationwide distribution.
device · product 2 of 2
Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
These labels are deterministic app interpretations, not FDA categories.
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
Code information
UPC: (01) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C
