Recall Z-0594-2026— Medtronic MiniMed, Inc.

Name: FDA recall Z-0594-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-21

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2025-10-21. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Medtronic MiniMed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-21
Firm location: Northridge, CA, United States

Product description

CareLink Clinic, REF: MMT-7350

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.