Quick Facts at a Glance
- Recall Date
- October 21, 2025
- Hazard Level
- HIGH
- Brand
- Medtronic MiniMed
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic MiniMed
- Product type
- CareLink Clinic Software
- Model numbers
- UDI-DI: 0763000B00008748K, Software Version: 4.2B
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 21, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic MiniMed, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
CareLink Clinic is used to review CGM data and support diabetes management. It integrates with Medtronic MiniMed systems and helps clinicians adjust therapy based on CGM readings.
Why This Is Dangerous
A software error can misrepresent the 24-hour glucose graph. Health decisions based on faulty data can cause hypo or hyperglycemia and associated health risks.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The error could affect treatment decisions across a global user base, potentially impacting patient safety and treatment outcomes. Immediate action matters to minimize risk.
Practical Guidance
How to identify if yours is affected
- Check if your CareLink Clinic device is MMT-7350.
- Verify UDI-DI: 0763000B00008748K.
- Check software version: 4.2B.
- Confirm whether your CGM data might have been influenced by the error.
Where to find product info
Look for the UDI, software version, and device label on the CareLink Clinic hardware or software interface. Review the recall notice for exact identifiers.
What timeline to expect
Refund or replacement processing typically takes 4-6 weeks after submission, though timelines vary by case.
If the manufacturer is unresponsive
- Document all communications with Medtronic Medical Support.
- Escalate to your healthcare provider or patient advocacy groups if responses are slow.
- Consider contacting the FDA if you believe you are not receiving timely remediation.
How to prevent similar issues
- Keep devices up to date with manufacturer software updates.
- Verify critical data with alternate readings when decisions may be made.
- Monitor for official recall notices and promptly implement guidance.
- When buying new devices, verify software version compatibility and update status.
Documentation advice
Save the recall notice, note the device model and serial/UDI, keep a log of communications with the manufacturer and provider, and document any therapy decisions affected by the faulty data.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
UDI-DI: 0763000B00008748K Software Versions: 4.2B Sold worldwide, including US states listed in the recall notice US clinical sale window: August 21, 2025 to October 04, 2025 OUS clinical sale window: September 11, 2025 to October 04, 2025 Price: Not disclosed
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDI-DI: 0763000B00008748K; Software Version: 4.2B
- Hazard: Software error mis-displays glucose data on 24-hour overview graph
- Geography: Worldwide distribution; US states listed; OUS countries listed
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.