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Tandem Diabetes Care, Inc.

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery recall (Z-1636-2026)Tandem Diabetes Care, Inc.2026-03-25
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated i recall (Z-0427-2026)Tandem Diabetes Care, Inc.2025-11-05
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070 recall (Z-0232-2026)Tandem Diabetes Care, Inc.2025-10-23
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) recall (Z-2621-2025)Tandem Diabetes Care, Inc.2025-09-24
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:s recall (Z-2343-2025)Tandem Diabetes Care, Inc.2025-08-27
t:slim X2 Insulin Pump with Interoperable Technology recall (Z-1519-2025)Tandem Diabetes Care, Inc.2025-04-11
Tandem Mobi Insulin Pump with Interoperable Technology recall (Z-1520-2025)Tandem Diabetes Care, Inc.2025-04-11
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ techn recall (Z-1609-2024)Tandem Diabetes Care, Inc.2024-05-06
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with recall (Z-1811-2022)Tandem Diabetes Care Inc2022-09-26
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with recall (Z-1812-2022)Tandem Diabetes Care Inc2022-09-26
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ recall (Z-1258-2022)Tandem Diabetes Care Inc2022-06-10
T:slim Insulin Delivery System Insulin Infusion Pump recall (Z-0827-2014)Tandem Diabetes Care Inc2014-02-10

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Every clearance here is in the API, with alerts when new ones post.