Tandem Diabetes Care Inc: 5 recalls on record

Recalls filed with 1 agency: FDA (5).

First recall on record: February 19, 2014. Most recent: October 29, 2025.

Risk classification: Class I: 2 · Class II: 3

Most recent recalls

DateAgencyProduct
October 29, 2025FDAt:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 101407…Z-0232-2026
May 15, 2024FDAt:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ tec…Z-1609-2024
October 5, 2022FDAt:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump wit…Z-1811-2022
June 22, 2022FDAt:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-I…Z-1258-2022
February 19, 2014FDAT:slim Insulin Delivery System Insulin Infusion PumpZ-0827-2014

Questions about this company

How many recalls does Tandem Diabetes Care Inc have?
Recalert has 5 U.S. recalls on record for Tandem Diabetes Care Inc, published between February 19, 2014 and October 29, 2025.
What was the most recent Tandem Diabetes Care Inc recall?
FDA recall Z-0232-2026, published October 29, 2025: 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 Inter…
Which agencies have handled Tandem Diabetes Care Inc recalls?
Tandem Diabetes Care Inc appears as the recalling firm in recalls from: FDA (5).

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