Z-0232-2026Class II

t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072...

Name: Z-0232-2026 t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072...
Creator: Tandem Diabetes Care, Inc.
Published: 2025-08-05
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2025-08-05 / Open, Classified / root cause: software

FDA source

Tandem Diabetes Care, Inc. began a recall of t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7... on 2025-08-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0232-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-05
Posted: 2025-10-23
Recalling firm: Tandem Diabetes Care, Inc.
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
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 8/5/2025, Field Safety Notices were sent to customers informing them of the following: Actions to avoid the issue: - Wait until your G7 sensor session ends before inserting a new G7 sensor. - However, if you do insert a new G7 sensor before your last sensor session ends, wait to pair until at least 20 minutes after the last session ends. Firm is working on a software update to resolve this issue. If you have questions or need help, please call firm's Customer Support 1-877-801-6901 or email [email protected]. Our team is available 24/7/365. On 9/16/2025, correction notices were emailed to customers who were informed the firm updated user guides to align with instructions in the correction notice. Also, the firm will notify impacted users via an updated Field Correction Notice when the software update is available. The notice will provide instructions on how to remotely update their software.
Quantity in commerce: 122,958
Distribution: US nationwide distribution including Puerto Rico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0232-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0232-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

Product code QFG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)