Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 13 FDA device recalls on record.
Top product codes for Tandem Diabetes Care, Inc.
FDA recalls by Tandem Diabetes Care, Inc.
10 most recent of 13- Z-1636-2026 — Tandem 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).
- Z-0427-2026 — 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, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081
- Z-0232-2026 — t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
- Z-2343-2025 — Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198
- Z-2621-2025 — t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
- Z-1519-2025 — t:slim X2 Insulin Pump with Interoperable Technology
- Z-1520-2025 — Tandem Mobi Insulin Pump with Interoperable Technology
- Z-1609-2024 — t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
- Z-1811-2022 — 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 with the Control-IQ Technology
- Z-1812-2022 — 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 with the Control-IQ Technology
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tandem Diabetes Care, Inc.
- K260429 — Control-IQ+ technology
- K253074 — Tandem Mobi insulin pump with interoperable technology
- K250792 — t:slim X2 insulin pump with interoperable technology
- K250798 — Control-IQ+ technology
- K243823 — Control-IQ+ technology
- K241078 — Tandem Mobi Insulin Pump with interoperable technology
- K240309 — Tandem Mobi insulin pump with interoperable technology
- K232380 — t:slim X2 Insulin Pump with Interoperable Technology
- K232382 — Control-IQ Technology
- K233044 — Tandem Mobi insulin pump with interoperable technology
- K223213 — Tandem Mobi Insulin Pump with Interoperable Technology
- K203234 — t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
- K200467 — Control-IQ Technology
- K201214 — t:slim X2 Insulin Pump with Interoperable Technology
- K193483 — Basal-IQ Technology
- DEN190034 — Control-IQ Technology
- DEN180058 — t:slim X2 insulin pump with interoperable technology
- K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K160056 — t:slim Insulin Delivery System
- K160482 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K143189 — t:flex Insulin Delivery System
- K141758 — T:SLIM INSULIN DELIVERY SYSTEM
- K133593 — T:SLIM INSULIN DELIVERY SYSTEM
- K122361 — T:CONNECT DATA MANAGEMENT SYSTEM
- K111210 — T:SLIM (TM) INSULIN DELIVERY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.