The FDA has posted 5 enforcement recalls of not for use with automated insulin delivery systems factory calibrated integrated continuous glucose monitoring system devices since 2025, including 4 Class I (most serious) recalls. Most recent report: Jan 21, 2026.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems”). Informational only — verify against the FDA before acting.