The Guardian Connect App CSS7200 iOS — Class II medical device recall Z-2980-2020
Terminated recall by Medtronic Inc., reported 2020-09-23. As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuou
| Recall number | Z-2980-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2020-07-15 |
| Classified | 2020-09-17 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2022-02-18 |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, KR, KW, LU, LV, MX, MY, NL, NZ, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, UA, VN, ZA |
| Quantity | 3,588 users |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000255404 |
Product
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Reason for recall
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
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-2980-2020. 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.