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Tandem Diabetes Care, Inc. FDA Recalls
10 recalls on file across devices, 5 of them Class I and 10 still open. Matched by name to TNDM.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize Class IIJan 30, 2026The Czech language user guide contained multiple translation |
| Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of bothClass IOct 6, 2025Insulin pump includes a vibration motor that gives tactile f |
| t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, aClass IIAug 5, 2025A software defect in versions 7.9.0.1 and 7.10.1 of the pump |
| Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, ReplacemenClass IJul 21, 2025Insulin pumps manufactured with speakers from Revision A and |
| t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)Class IIJul 3, 2025an app defect that occurs when the phone is set to a right- |
| Tandem Mobi Insulin Pump with Interoperable TechnologyClass IFeb 27, 2025A software defect in Version 7.9 of the pump software for Ta |
| t:slim X2 Insulin Pump with Interoperable TechnologyClass IFeb 27, 2025A software defect in Version 7.9 of the pump software for Ta |
| t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technologyClass IMar 5, 2024During normal use, the mobile app version 2.7 may crash and |
| t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim Class IIMay 24, 2022Insulin pumps may have the following issues: 1) Malfunction |
| t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim Class IIMay 24, 2022Insulin pumps may have the following issues: 1) Malfunction |