Brand

Tandem Diabetes Care, Inc. Recalls

10 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Tandem Diabetes Care, Inc..

10Total Recalls
3Critical
426,793Units Affected
Jan 30, 2026Most Recent
All Recalls

Every Tandem Diabetes Care, Inc. Recall

Sorted by most recent. Click any recall for full details.

10 recalls
High RiskFDA
Tandem Diabetes Care, Inc.
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven me...
Diabetes Devices·1,380 affected·Jan 30, 2026
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide whe...
Diabetes Devices·122,958 affected·Aug 5, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, R...
Medical Devices·171,750 affected·Jul 21, 2025
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Diabetes Devices·19 affected·Jul 3, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology
Diabetes Devices·63 affected·Feb 27, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Diabetes Devices·85,863 affected·Mar 5, 2024
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump w...
Diabetes Devices·31,100 affected·May 24, 2022
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump w...
Diabetes Devices·8,399 affected·May 24, 2022
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Diabetes Devices·5,206 affected·Sep 10, 2020
High RiskFDA
Tandem Diabetes Care Inc
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary R...
Diabetes Devices·55 affected·Apr 23, 2018