Quick Facts at a Glance
- Recall Date
- May 7, 2025
- Hazard Level
- HIGH
- Brand
- Medtronic MiniMed
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- CGM Sensor
- Model numbers
- MMT-5100JD1, HG81GLZ GTIN: 20763000649580
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 7, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
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
The Simplera Sensor is part of a continuous glucose monitoring system used by people with diabetes to monitor glucose levels.
Why This Is Dangerous
A device cap label may not adhere to the sensor. This can compromise sterility and increase the risk of infection for users.
Industry Context
This recall is not described as part of a broader industry pattern in the provided materials.
Real-World Impact
Consumers outside the US may be affected. Immediate cessation of use is advised to mitigate infection risk and ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Verify model REF MMT-5100JD1.
- Check Lot HG81GLZ and GTIN 20763000649580.
- Confirm distribution country outside the US (Austria, Belgium, Italy, Spain, Switzerland, United Kingdom).
Where to find product info
Recall details available on the FDA enforcement page linked in the notice.
What timeline to expect
Replacement or remedy timelines are not specified; expect guidance from Medtronic MiniMed or healthcare providers.
If the manufacturer is unresponsive
- File a complaint with the FDA if the manufacturer is unresponsive.
- Contact your healthcare provider for alternatives and safe usage guidance.
- Keep documentation of all outreach and responses.
How to prevent similar issues
- Always verify device labeling and packaging upon receipt.
- Monitor for sterility indicators and avoid using devices with damaged seals.
- Stay informed on FDA recalls for medical devices you use.
- When purchasing medical devices, verify regulatory approvals and recall history.
Documentation advice
Keep recall notification, model and lot numbers, purchase receipts (if available), and all correspondence with the manufacturer or healthcare providers.
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Product Details
Model numbers: MMT-5100JD1; Lot HG81GLZ; GTIN 20763000649580. Sold outside the United States in Austria, Belgium, Italy, Spain, Switzerland and the United Kingdom. Recall date: 2025-05-07. Quantity: 1,440 units. Price: Unknown. Remembered recall status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- REF: MMT-5100JD1
- European distribution in 6 countries
- Label adhesion defect risks sterility and infection
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Safety Guide
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