t:slim X2 insulin pump with Interoperable Technology — Class II medical device recall Z-0232-2026
Ongoing recall by Tandem Diabetes Care, Inc., reported 2025-10-29, distributed nationwide. A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1
| Recall number | Z-0232-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care, Inc., San Diego, CA, United States |
| Recall initiated | 2025-08-05 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 122,958 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00389152407012, 00389152407111, 00389152407210, 00389152407319, 00389152480114, 00389152481111, 00389152481319 |
| Model numbers | 1014070, 1014071, 1014072, 1014073, 1014801, 1014811, 1014813 |
Product
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
Reason for recall
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0232-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.