Tandem Diabetes Care, Inc.
Complete recall history across all FDA and CPSC categories — 8 total recalls
Tandem Diabetes Care, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (8)
FDA medical device enforcement actions by Tandem Diabetes Care, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 30, 2026 | Tandem pumps are battery-operated infusion pumps capable of both basal and bo... | The Czech language user guide contained multiple translation errors. The mos... | Class II |
| Oct 6, 2025 | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... | Insulin pump includes a vibration motor that gives tactile feedback for any a... | Class I |
| Aug 5, 2025 | t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,... | A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tan... | Class II |
| Jul 21, 2025 | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:... | Insulin pumps manufactured with speakers from Revision A and B may malfunctio... | Class I |
| Jul 3, 2025 | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobi... | an app defect that occurs when the phone is set to a right-to-left language,... | Class II |
| Feb 27, 2025 | Tandem Mobi Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 an... | Class I |
| Feb 27, 2025 | t:slim X2 Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 an... | Class I |
| Mar 5, 2024 | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... | During normal use, the mobile app version 2.7 may crash and be automatically ... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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