Tandem Diabetes Care, Inc.
8 federal recalls on file, showing the 4 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Tandem Diabetes Care, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-01FDA-DeviceClass IICheck your Tandem pump's Czech language guide
Tandem Diabetes Care insulin pumps distributed in the Czech Republic and Slovakia have translation errors in their Czech language user guide. The most serious error tells users to verify the infusion set is connected to the body when it should say the opposite—that it should NOT be connected. Following these incorrect instructions could cause unintended insulin delivery and dangerously low blood sugar.
- 2025-11-12FDA-DeviceClass ITandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi,
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
- 2025-10-29FDA-DeviceClass IITandem insulin pumps recalled for unexpected insulin dose risk
Tandem Diabetes Care insulin pumps (t:slim X2 and Mobi models) with certain software versions may deliver an unexpected automatic insulin correction dose when paired with a Dexcom G7 sensor. This could cause low blood sugar (hypoglycemia). The issue affects specific software versions: t:slim X2 versions 7.9.0.1 and 7.10.1, and Mobi version 7.9.0.1.
- 2025-10-01FDA-DeviceClass IIt:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
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