Z-2778-2026Class II

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

Name: Z-2778-2026 MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Creator: Medtronic MiniMed, Inc.
Published: 2026-06-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-06-16 / Open, Classified / root cause: software

FDA source

Medtronic MiniMed, Inc. began a recall of MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) on 2026-06-16. FDA classified it as Class II and gives the reason as "For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2778-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-16
Posted: 2026-07-23
Recalling firm: Medtronic, Inc.
Product: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Product code: NDC Calculator, Drug Dose
Reason for recall: For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
Root cause tag: software
FDA root cause: Software design
Action: On 6/16/2026 In-App Push Notifications were sent to customers entitled, Important Field Safety Corrective Action required on your MiniMed Go app. informing them a software upgrade is available to ensure important nighttime notifications are received. Correction notices were also emailed to customers informing them to update to version 1.2.0 or higher. For iOS Users: To confirm the latest app version on your iOS device, follow the steps below: 1. Open the App Store. 2. Tap your profile icon at the top of the screen. 3. Scroll to see pending updates. 4. Tap Update next to the MiniMed Go app icon. For Android Users: To confirm the latest app version on your Android device, follow the steps below: 1. Open the Google Play Store. 2. Tap Menu, then select Manage apps & device. 3. Apps with an update available are labeled "Update available." You can also search for the MiniMed Go app. 4. Tap Update next to the MiniMed Go app icon. Acknowledge that you have read and understood the notification by clicking the acknowledgement button or visiting https://www.minimed.com/en-us/safety-notices/notice31-letter If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.
Quantity in commerce: 3,465
Distribution: Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.
Product codes and lots: Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2778-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2778-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23

Product code NDC

K253512Class IIMiniMed Go AppMedtronic Minimed / cleared 2026-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)