Medtronic MiniMed, Inc. recalls CareLink Clinic, REF: MMT-7350

Recall date

October 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0594-2026

FDA classification

Class II

Brand / firm

Medtronic MiniMed, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA, VA, ID, WA, GA, MI, MA, OH, IL, IA, CT, FL, PA, NY, TN, AZ, LA, AL, NJ, CO, SC, MS, OR, MT, MD, KS, AK, NH, NE, WY, ND, IN, MO, WI, KY, UT, NV, SD, WV, NM, HI, AR, OK, VT, RI; and OUS (foreign) to countries of: Australia (…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CareLink Clinic, REF: MMT-7350