Use cautionMedical device recall · FDA · Published August 5, 2025
Tandem t:slim X2 and Mobi insulin pumps with G7 sensor risk hypoglycemia
Tandem recalls t:slim X2 and Mobi insulin pumps with Dexcom G7 sensors using specific software versions that may cause unexpected insulin doses leading to low blood sugar.
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.
Take action
Contact the company
📍Recalling firmTandem Diabetes Care, Inc.12400 High Bluff Dr · San Diego, CA 92130-3077
“Tandem t:slim X2 and Mobi insulin pumps with G7 sensor risk hypoglycemia.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51680-tandem-t-slim-x2-and-mobi-insulin-pumps-with-g7. Based on FDA recall #Z-0232-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0232-2026%22&limit=1).
The FDA announced on 2025-08-05 that Tandem Diabetes Care, Inc. is recalling t:slim X2 and Tandem Mobi insulin pumps due to a software defect that may cause unexpected automatic insulin correction boluses. This defect could result in hypoglycemia for users paired with a G7 sensor.
Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813
t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.10.1
Tandem Mobi, UDI-DI: 00389152480114, 00389152481111, 00389152481319 with software version 7.9.0.1
The hazard
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 paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus). This could result in hypoglycemia.
Context
GovInfoNow's records show Tandem Diabetes Care, Inc. has had 10 other recalls since 2018-04-23. Other recent recalls include the t:slim Mobile Application recall on 2026-07-16, pumps with Czech guide errors on 2026-01-30, and Tandem Mobi Insulin Pump false vibration motor failure risk on 2025-10-06. Other recent recalls of similar products include Medtronic MiniMed 670G Insulin Pump Recall (2026-02-13), Medtronic Paradigm Insulin Pumps Recall (2026-02-13), and Medtronic MiniMed 620G Insulin Pump Recall (2026-02-13).
How to tell if you have this one
Check for the pump model (t:slim X2 or Mobi) and software version numbers (7.9.0.1 or 7.10.1 for t:slim X2, 7.9.0.1 for Mobi) when paired with a Dexcom G7 sensor. The product has specific reference numbers listed in the recall notice.
Brand
Tandem
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Pump Software Version
Look for the software version on your pump's display or in the user guide. Versions 7.9.0.1 or 7.10.1 for t:slim X2 and 7.9.0.1 for Mobi are affected.
Update Software
Contact Tandem support to update to a newer software version that fixes this issue. They may provide a software update or replacement pump.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US nationwide distribution including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
No, the recall does not require immediate stoppage. You can continue using the pump but should update the software to a newer version to avoid the risk.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0232-2026 (August 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0232-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.