Guardian Connect App CSS7200 used on the iPhone — Class II medical device recall Z-1282-2019
Terminated recall by Medtronic Inc., reported 2019-05-15. The application may be closed by the operating system without alerting the user the app is no longer running o
| Recall number | Z-1282-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2018-07-04 |
| Classified | 2019-05-03 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2022-06-06 |
| Countries outside the US | AT, AU, BE, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, HU, IE, IL, IS, IT, KR, LU, NL, NO, PL, QA, RO, SA, SE, SG, SI, SK, TR, ZA |
| Quantity | 9,328 registered |
| UPC / GTIN / UDI-DI | 00643169693142 |
Product
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Reason for recall
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
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-1282-2019. 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.