Quick Facts at a Glance
- Recall Date
- February 13, 2026
- 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
- Insulin Pump
- Model numbers
- MiniMed 620G Insulin Pump, Paradigm series, 600 series, BLE 700 series
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 13, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
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
Medtronic MiniMed insulin pumps automate or assist insulin delivery for diabetes management. The 620G is part of older Paradigm/600 BLE lines and may connect with continuous glucose monitoring systems.
Why This Is Dangerous
The device's height relative to the infusion site affects hydrostatic and hydrodynamic pressures, causing potential insulin over-delivery or under-delivery.
Industry Context
This recall is not presented as part of a broader industry pattern in the provided data.
Real-World Impact
Patients may experience severe hypo- or hyperglycemia, requiring urgent medical care. The recall affects 799 units across a wide distribution network worldwide.
Practical Guidance
How to identify if yours is affected
- Check model numbers on device label and user manual
- Look up UDI-DI on packaging or device label
- Review recall notices for affected series (Paradigm, 600, BLE 700)
- Record date codes and serial numbers if available
Where to find product info
Device labels, user manuals, recall notices, FDA enforcement page
What timeline to expect
Refunds or replacements typically take 4-8 weeks after submission
If the manufacturer is unresponsive
- Escalate to FDA recall complaint channels
- Keep a detailed log of contacts
- Seek legal advice if delays are prolonged
How to prevent similar issues
- Register for recall alerts from Medtronic and FDA
- Verify device status before use or replacement
- Ask healthcare providers about newer pump models with updated safety features
- Monitor for recall updates on official sites
Documentation advice
Keep all recall notices, device serial numbers, photos of labels, receipts, and all correspondence with Medtronic.
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Product Details
Model numbers and devices affected include MiniMed 620G insulin pump and related Paradigm, 600, and BLE 700 series pumps. Distribution is worldwide, including US states and many countries.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- High hazard level
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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