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Active recall record

Tandem Mobi Insulin Pump

Tandem Diabetes Care, Inc. · Insulin pumps · Model family Tandem Mobi Insulin Pump

Insulin infusion pump

3 ongoing recall records reference this device, out of 3 total records tracked.

Published Aug 2, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Recall records referencing this device

Class I recallOngoing

Tandem Mobi Insulin Pump recall — FDA event 97662

Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer…

FDA · FDA event 97662Posted Nov 5, 2025

Class II recallOngoing

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

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…

FDA · FDA event 97403Posted Oct 23, 2025

Class I recallOngoing

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at…

FDA · FDA event 96417Posted Apr 11, 2025

Affected models, lots, and serial ranges

Models of Tandem Mobi Insulin Pump referenced by recall records
Model	Description	Lot / serial range	Manufactured	Status
Z-0427-2026	Z-0427-2026	Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170	Not provided in the normalized record	Ongoing
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
Z-1520-2025	Z-1520-2025	Software versions 7.9/UDI: 00389152480114	Not provided in the normalized record	Ongoing
Z-1519-2025	Z-1519-2025	Software versions 7.9/UDI: 00389152407012	Not provided in the normalized record	Ongoing

Device facts

Manufacturer: Tandem Diabetes Care, Inc.
Category: Insulin pumps
FDA generic device type: Insulin infusion pump
Regulatory class: Not specified

Official sources

U.S. Food and Drug Administration Global Unique Device Identification Database

Identifier: Primary DI 00389152547244
Published: Dec 16, 2025
Source checked: 2026-10-08 17:47:58 UTC

Representative FDA UDI identity record for this canonical launch device family.

View official record

U.S. Food and Drug Administration

Identifier: 97662
Published: Nov 5, 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

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

U.S. Food and Drug Administration

Identifier: 96417
Published: Apr 11, 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

Insulin infusion pump

3 ongoing recall records reference this device, out of 3 total records tracked.

Published Aug 2, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Recall records referencing this device

Class I recallOngoing

Tandem Mobi Insulin Pump recall — FDA event 97662

FDA · FDA event 97662Posted Nov 5, 2025

Class II recallOngoing

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

FDA · FDA event 97403Posted Oct 23, 2025

Class I recallOngoing

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

FDA · FDA event 96417Posted Apr 11, 2025

Affected models, lots, and serial ranges

Models of Tandem Mobi Insulin Pump referenced by recall records
Model	Description	Lot / serial range	Manufactured	Status
Z-0427-2026	Z-0427-2026	Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170	Not provided in the normalized record	Ongoing
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
Z-1520-2025	Z-1520-2025	Software versions 7.9/UDI: 00389152480114	Not provided in the normalized record	Ongoing
Z-1519-2025	Z-1519-2025	Software versions 7.9/UDI: 00389152407012	Not provided in the normalized record	Ongoing

Official sources

U.S. Food and Drug Administration Global Unique Device Identification Database

Identifier: Primary DI 00389152547244
Published: Dec 16, 2025
Source checked: 2026-10-08 17:47:58 UTC

Representative FDA UDI identity record for this canonical launch device family.

View official record

U.S. Food and Drug Administration

Identifier: 97662
Published: Nov 5, 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

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

U.S. Food and Drug Administration

Identifier: 96417
Published: Apr 11, 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

How MedWatcher checks these sources

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Tandem Mobi Insulin Pump

Follow Tandem Mobi Insulin Pump

Recall records referencing this device

Tandem Mobi Insulin Pump recall — FDA event 97662

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

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

Affected models, lots, and serial ranges

Device facts

Tandem Mobi Insulin Pump

Follow Tandem Mobi Insulin Pump

Recall records referencing this device

Tandem Mobi Insulin Pump recall — FDA event 97662

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

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

Affected models, lots, and serial ranges

Device facts