FDA Device recall Z-0776-2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system by Medtronic Minimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0776-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-21 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Minimed |
| Distribution | n/a |
Product
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Reason
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.
Identifiers
| code_info | App Version 1.3.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0776-2023%22
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