FDA Device recall Z-0232-2026
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when…
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when… by Tandem Diabetes Care, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0232-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-05 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tandem Diabetes Care |
| Distribution | US |
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
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.
Identifiers
| code_info | t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.…t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.10.1, User Guide versions not including and prior to: AW-1014562 Revision D; Tandem Mobi, UDI-DI: 00389152480114, 00389152481111, 00389152481319 with software version 7.9.0.1, User Guide versions not including and prior to: AW-1014938 Revision C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0232-2026%22
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