Class II — Medtronic Inc.
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. |
| Quantity | Approximately 9,328 registered users |
| Distribution | Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovaki… |
| Initiated | 2018-07-04 |
| Classified | 2019-05-03 |
| Terminated | 2022-06-06 |
| Recall number | Z-1282-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Inc. (Z-1282-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81656/
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