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
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Code information
Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
Distribution pattern
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
device · product 2 of 3
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Code information
Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
Distribution pattern
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
device · product 3 of 3
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Code information
Model No 63910. UDI-DI (01)1038548063910. Software Versions: v0.0.13.10 to v0.0.13.44.
Distribution pattern
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
