The FDA has posted 6 enforcement recalls of prescription use blood glucose meter for near-patient testing devices since 2025, including 6 Class I (most serious) recalls. Most recent report: Sep 23, 2026.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) b…
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) b…
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) b…
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) b…
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) b…
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…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Prescription Use Blood Glucose Meter For Near-Patient Testing”). Informational only — verify against the FDA before acting.