Class I recallOngoing

Tandem Mobi Insulin Pump recall — FDA event 97662

FDA · FDA event 97662 · Posted Nov 5, 2025

Published Nov 5, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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 receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.

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 10/6/2025, correction notices were mailed or emailed to customers who were informed the following:
If your pump shows Malfunction 12, insulin delivery will stop, and the pump becomes non-operational: 1) Promptly acknowledge it by pressing "Silence Alarm". 2) Contact Tandem Diabetes Care Customer Technical Support (CTS) via phone at 1-877-801-6901 or email at Techsupport@tandemdiabetes.com for further assistance. 3) Switch to your backup method of insulin delivery as directed by your physician. 4) Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings.
Update your pump software as soon as possible to version 7.9.0.2. You can check your software version within the Mobi Mobile App. Select Settings > Pump > Pump Info.
The latest software can be downloaded remotely from within the Tandem Mobi Mobile App. Once logged in to the app, tap "Settings" and then "Pump" to view software updates.
Complete the acknowledgement form using link: https://campaign.tandemdiabetes.com/FCA-Malfunction-12
User Guide: https://www.tandemdiabetes.com/docs/default-source/user-guide/user-guide-tandem-mobi-control-iq-7-9-mgdl-en-us-aw1014938.pdf?sfvrsn=872fc4d7_10

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 by Tandem Diabetes Care, Inc..

Products affected by FDA event 97662
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

Distribution: US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Oct 6, 2025
Recall initiated
Date recorded by the FDA.
Nov 5, 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: 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

How MedWatcher checks these sources

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Tandem Mobi Insulin Pump recall — FDA event 97662

FDA · FDA event 97662 · Posted Nov 5, 2025

Published Nov 5, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 97662
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

Distribution

US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY

Units affected

See official FDA record

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

FDA · FDA event 97403Posted Oct 23, 2025Tandem Mobi Insulin Pump,Tandem t:slim X2 Insulin Pump

Class I recallOngoing

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

FDA · FDA event 96417Posted Apr 11, 2025Tandem Mobi Insulin Pump,Tandem t:slim X2 Insulin Pump

Tandem Mobi Insulin Pump recall — FDA event 97662

Follow Tandem Mobi Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Tandem Mobi Insulin Pump recall — FDA event 97662

Follow Tandem Mobi 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