Tandem Diabetes Care recalls
Tandem Diabetes Care appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin
FDA Device · Class II · 2026-04-01 · Tandem Diabetes Care - Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus del…
FDA Device · Class I · 2025-11-12 · Tandem Diabetes Care - t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when…
FDA Device · Class II · 2025-10-29 · Tandem Diabetes Care - t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
FDA Device · Class II · 2025-10-01 · Tandem Diabetes Care - Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911
FDA Device · Class I · 2025-09-03 · Tandem Diabetes Care - Tandem Mobi Insulin Pump with Interoperable Technology
FDA Device · Class I · 2025-04-23 · Tandem Diabetes Care - t:slim X2 Insulin Pump with Interoperable Technology
FDA Device · Class I · 2025-04-23 · Tandem Diabetes Care - t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
FDA Device · Class I · 2024-05-15 · Tandem Diabetes Care - t:slim X2 insulin pump
FDA Device · Class II · 2022-10-05 · Tandem Diabetes Care - t:slim X2 insulin pump
FDA Device · Class II · 2022-10-05 · Tandem Diabetes Care - t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
FDA Device · Class II · 2022-06-22 · Tandem Diabetes Care - t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B
FDA Device · Class II · 2018-07-25 · Tandem Diabetes Care - T:slim Insulin Delivery System Insulin Infusion Pump
FDA Device · Class I · 2014-02-19 · Tandem Diabetes Care