FDA Device recall Z-1282-2019
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices
- FDA Device
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices by Medtronic, citing 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 receiv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1282-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-04 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic |
| Distribution | n/a |
Product
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
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.
Identifiers
| code_info | UDI - (01)00643169693142(10) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.