Guardian iOS app — Class II medical device recall Z-0776-2023
Ongoing recall by Medtronic MiniMed, reported 2023-01-11. An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log
| Recall number | Z-0776-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Northridge, CA, United States |
| Recall initiated | 2022-11-21 |
| Classified | 2022-12-31 |
| Reported by FDA | 2023-01-11 |
| Countries outside the US | AE, AT, BE, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IS, IT, KW, LU, NL, NO, NZ, PL, PT, QA, RO, RS, SA, SE, SI, SK, TN, TR, UA, ZA |
| Quantity | 3,235 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0776-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.