Medtronic MiniMed Go App Recall Due to Missed Alerts

Source: FDA · Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medtronic MiniMed is recalling 3,465 units of its MiniMed Go App (models MMT-8600 and MMT-8601) after a software issue that may prevent nighttime alerts for missed insulin doses.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 12, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

Medtronic MiniMed, Inc. initiated a voluntary recall of the MiniMed Go App after determining that versions 1.0.0 and 1.1.0 may fail to trigger "missed dose" or "Correct high glucose" alerts during nighttime hours when the "Set day and night" feature is turned off.

Which Products Are Affected

The recall covers the MiniMed Go App, Model MMT-8600 (iOS) and MMT-8601 (Android), software versions 1.0.0 and 1.1.0. A total of 3,465 units are affected. The recall number is Z-2778-2026. Distribution includes the United States nationwide and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, and Sweden.

What You Should Do

Consumers should contact Medtronic MiniMed for further instructions regarding the software issue. The firm initiated the recall via letter on June 16, 2026.

Why This Matters

The defect may result in missed rapid-acting insulin doses without user knowledge, leading to delayed therapy and increased risk of hyperglycemia.

Source

FDA recall Z-2778-2026, Class II, ongoing.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic MiniMed is recalling 3,465 units of its MiniMed Go App (models MMT-8600 and MMT-8601) after a software issue that may prevent nighttime alerts for missed insulin doses.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.