Class II recallOngoing

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

FDA · FDA event 97403 · Posted Oct 23, 2025

Published Oct 23, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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 Techsupport@tandemdiabetes.com. 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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc..

Products affected by FDA event 97403
Model	Description	Lot / serial range	Manufactured	Status
Z-0232-2026	Z-0232-2026	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	Not provided in the normalized record	Ongoing

Distribution: US nationwide distribution including Puerto Rico.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Aug 5, 2025
Recall initiated
Date recorded by the FDA.
Oct 23, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97403
Published: Oct 23, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

FDA · FDA event 97403 · Posted Oct 23, 2025

Published Oct 23, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 97403
Model	Description	Lot / serial range	Manufactured	Status
Z-0232-2026	Z-0232-2026	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	Not provided in the normalized record	Ongoing

Distribution

US nationwide distribution including Puerto Rico.

Units affected

See official FDA record

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

Follow Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

Follow Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline