Use caution Medical device recall · FDA · Published October 6, 2025

Tandem Mobi Insulin Pump Recall: False Vibration Motor Failure Risk

Tandem recalls Mobi insulin pumps with software version 7.6.0.3 and 7.7 that may show false vibration motor failure, risking hyperglycemia. Learn what to do.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0427-2026Medical device Tandem ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmTandem Diabetes Care, Inc.12400 High Bluff Dr · San Diego, CA 92130-3077

✎ GovInfoNow plain-language explainer

Tandem is recalling certain Mobi insulin pumps that have a software issue causing false vibration motor failures. This could stop insulin delivery and lead to high blood sugar levels if the pump malfunctions. Read more at govinfonow.com/recall/51112-tandem-mobi-insulin-pump-recall-false-vibration-motor-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51112-tandem-mobi-insulin-pump-recall-false-vibration-motor-failure-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0427-2026

Cite this page

“Tandem Mobi Insulin Pump Recall: False Vibration Motor Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51112-tandem-mobi-insulin-pump-recall-false-vibration-motor-failure-risk. Based on FDA recall #Z-0427-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0427-2026%22&limit=1).

The FDA announced on Oct. 6, 2025, that Tandem Diabetes Care, Inc. is voluntarily recalling the Tandem Mobi insulin pump due to a software issue causing false vibration motor failure and potential hyperglycemia. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Tandem
Product: Tandem Mobi Insulin Pump
Catalog Numbers: 1010750, 1012719, 1013501, 1013655, 1013656, 1013700, 1014081
Software Versions: 7.6.0.1, 7.6.0.3, 7.7.0.1
Units Affected: 17,745

The hazard

The pump's vibration motor may fail due to a software issue, triggering Malfunction 12 which stops insulin delivery and data transmission to the mobile app. This malfunction could result in hyperglycemia.

Context

GovInfoNow's records show Tandem Diabetes Care, Inc. has 10 other recalls on record since April 23, 2018. Other recent recalls of similar products include the Tandem t:slim mobile application (July 16, 2026), Tandem pumps with Czech guide errors (Jan. 30, 2026), and Tandem t:slim X2 and Mobi insulin pumps with G7 sensor risk hypoglycemia (Aug. 5, 2025). Other recent recalls of similar products include the Medtronic MiniMed 780G Insulin Pump Recall (July 13, 2026), the Medtronic MiniMed 630G Insulin Pump Recall (Feb. 13, 2026), and the Medtronic MiniMed 640G Insulin Pump Recall (July 13, 2026).

How to tell if you have this one

Check for software versions 7.6.0.3 or 7.7 on your Tandem Mobi pump. The product was sold with specific catalog numbers and UDI-DI codes 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 pump's settings menu.
Contact Tandem Support
If your pump has software version 7.6.0.3 or 7.7, contact Tandem Diabetes Care for guidance on next steps.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 37 days after the firm started it.

Oct 6, 2025Firm started the recall
Nov 5, 2025FDA classified it Class I
Nov 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/51112-tandem-mobi-insulin-pump-recall-false-vibration-motor-failure-risk">Tandem Mobi Insulin Pump Recall: False Vibration Motor Failure Risk (GovInfoNow)</a>

Where this comes from

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-0427-2026 (October 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0427-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.