Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 11, 2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logg…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic MiniMed recalled Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 s… - a moderate-severity action.
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 s… was recalled by Medtronic MiniMed in January 11, 2023. Reason: An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log…. Check the official notice for the remedy. Verify recall #Z-0776-2023 with the FDA Devices before acting.
The recall
Medtronic MiniMed issued this moderate-severity FDA Devices recall-An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- January 11, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0776-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0776-2023) was formally reported on January 11, 2023, with the manufacturer initiating the action on November 21, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic MiniMed is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 3235.
The documented reason for this recall is: An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not re… Distribution data in the federal record shows the product reached: OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Nether…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3235
Related Recalls
6
3 from same agency
Product description
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Reason for recall
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0776-2023 |
| Date reported | January 11, 2023 |
| Date initiated | November 21, 2022 |
| Recalling firm | Medtronic MiniMed |
| Firm location | Northridge, CA |
| Affected scope | 3235 |
| Distribution | OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0776-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system. Recalled by Medtronic MiniMed. Units affected: 3235.
Why was this product recalled? ▼
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0776-2023.
Where was the recalled product distributed? ▼
Distribution: OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0776-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 11, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.