Tandem Diabetes Care recalls
9 federal recalls on file, showing the 4 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Tandem Diabetes Care and put it in plain English.
Recent recalls
Tandem Mobi insulin pumps recalled for false occlusion alarmsTandem Diabetes Care found that some Tandem Mobi insulin pumps can give false occlusion alarms when no blockage is present. This can cause the pump to stop insulin delivery until the user acknowledges the alarm and restarts therapy. Repeated interruptions could lead to high blood glucose, and in severe cases may require medical care or hospitalization.
SeriousFDAOct 30, 2026
- Tandem t:slim app recalled for Libre 3 Plus pairing failure
A beta version of the Tandem t:slim iOS app (version 2.13) has a software bug that prevents it from connecting to Abbott FreeStyle Libre 3 Plus glucose monitors. Users affected by this issue cannot see their blood sugar readings in the app and cannot use automated insulin delivery; they must switch to manual pump mode instead.
ModerateFDAOct 7, 2026
- Tandem insulin pumps recalled for Czech guide translation errors
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.
ModerateFDAApr 1, 2026
- Tandem 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.
FDANov 12, 2025