FDA Device recall Z-0594-2026
CareLink Clinic, REF: MMT-7350
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of CareLink Clinic, REF: MMT-7350 by Medtronic Minimed, citing software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0594-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-21 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Minimed |
| Distribution | US |
Product
CareLink Clinic, REF: MMT-7350
Reason
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Identifiers
| code_info | UDI-DI: 0763000B00008748K. Software Versions: 4.2B Software Available: US: Between September 4th, 2025, and October 3…UDI-DI: 0763000B00008748K. Software Versions: 4.2B Software Available: US: Between September 4th, 2025, and October 3rd, 2025. OUS: Between September 11th, 2025, and October 4th, 2025. US (Clinical): Between August 21st, 2025, and October 3rd, 2025. OUS (Clinical): Between August 21st, 2025, and October 4th, 2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0594-2026%22
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