MiniMed Go recallZ-2778-2026 · Medtronic MiniMed, Inc. · initiated Jun 16, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic MiniMed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2778-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 16, 2026
- Posted by the FDA
- Jul 23, 2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Quantity
- 3,465
- Product code
- NDC
- FDA submissions
- K253512
- 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 description
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MiniMed Go MMT-8600Medtronic Minimed, Inc. · Calculator, drug dose1 recall0 reports
- MiniMed Go MMT-8601Medtronic Minimed, Inc. · Calculator, drug dose1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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