Tandem Diabetes Care recalled 122,958 insulin pumps on August 5, 2025. A software defect may cause unexpected insulin boluses, leading to hypoglycemia. Patients should stop using the devices immediately and follow the manufacturer's instructions.
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
The recall affects the t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology. The affected model numbers include REF: 1014070, 1014071, 1014072, 1014073, and others. The pumps were sold nationwide in the U.S. and Puerto Rico.
A software defect in versions 7.9.0.1 and 7.10.1 may result in automatic insulin correction boluses. These unexpected boluses can lead to hypoglycemia, a serious health risk for users.
There have been no specific injury reports associated with this recall. However, the potential for hypoglycemia poses a significant health risk to users.
Patients and healthcare providers should stop using the affected devices immediately. Contact Tandem Diabetes Care, Inc. or your healthcare provider for further instructions and follow the recall process outlined in notification letters.
For more details, contact Tandem Diabetes Care at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0232-2026.
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