Lower riskMedical device recall · FDA · Published October 21, 2025
Medtronic CareLink Clinic Software Error May Cause Incorrect Glucose Readings
Medtronic recalls CareLink Clinic REF: MMT-7350 due to software error causing incorrect glucose data displays, which could lead to unsafe blood sugar levels. Affected users should check their device software version.
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.
Take action
Contact the company
📍Recalling firmMedtronic MiniMed, Inc.18000 Devonshire St · Northridge, CA 91325-1219
“Medtronic CareLink Clinic Software Error May Cause Incorrect Glucose Readings.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51038-medtronic-carelink-clinic-software-error-may-cause-incorrect-glucose-readings. Based on FDA recall #Z-0594-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0594-2026%22&limit=1).
The FDA announced on Oct. 21, 2025, that Medtronic MiniMed, Inc. is recalling CareLink Clinic (REF: MMT-7350) due to a software error displaying incorrect data on the 24-hour Sensor Glucose Overview Graph. This hazard may lead users to make therapy decisions based on false information, potentially causing hypoglycemia or hyperglycemia.
How to tell if you have it
Brand: Medtronic
Product: CareLink Clinic
REF: MMT-7350
UDI-DI: 0763000B00008748K
Software Versions: 4.2B
Units affected: 12,126
The hazard
A software error causes incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph. Any potential therapy decisions made based on this incorrect data may lead to hypoglycemia or hyperglycemia.
Context
GovInfoNow's records show Medtronic MiniMed, Inc. has 13 other recalls on record since Nov. 15, 2023. Recent recalls include a June 16, 2026, issue with the MiniMed Go App that may cause missed insulin doses and a May 27, 2026, recall of the MiniMed 780G Insulin Pump for software errors causing insulin stoppage. Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter Software Issue Causes Patient Data Errors (July 29, 2026) and Dexcom G7 CGM App: Hypoglycemia Risk Due to Glucose Data Delays (April 14, 2026).
How to tell if you have this one
Check if your CareLink Clinic device shows software version 4.2B. The device was sold between September 4th, 2025, and October 3rd, 2025, in the US, and between September 11th, 2025, and October 4th, 2025, outside the US.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version on your CareLink Clinic device. If it shows 4.2B, you are affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0594-2026 (October 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0594-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.