What is being recalled?

Medtronic MiniMed Simplera Sensor units with REF MMT-5100JD1 are recalled due to a device cap label that may not adhere, potentially compromising sterility and increasing infection risk.

How many units are affected?

1,440 units are affected by this recall, distributed outside the United States in Austria, Belgium, Italy, Spain, Switzerland and the United Kingdom.

Are there any injuries reported?

No injuries or incidents have been reported to date.

Which models or lot numbers are involved?

Model REF MMT-5100JD1 with Lot HG81GLZ and GTIN 20763000649580.

Where should I look for recall information?

Refer to the FDA enforcement notice linked to the recall: Z-0033-2026.

What should I do if I own this device?

Stop using the device and follow the instructions provided by Medtronic MiniMed or your healthcare provider.

Will I get a replacement or refund?

The recall notice directs users to stop use and follow manufacturer instructions. Specific replacement or refund details are not listed in the provided materials.

How can I contact Medtronic MiniMed about this recall?

Contact the recall through the official FDA notice page. Direct phone numbers or hours were not listed in the provided data.

Is this recall limited to Europe?

Yes. The distribution noted is outside the US, specifically in Austria, Belgium, Italy, Spain, Switzerland and the United Kingdom.

What are the infection risks involved?

Compromised sterility of the sensor increases the potential for infection in users who rely on this CGM device.

How long will it take to resolve the recall?

timelines for resolution or replacement are not specified in the provided materials.

What should I document if I contact the manufacturer?

Keep records of recall notices, model and lot numbers, dates of purchase, and any correspondence with the company or healthcare providers.

HIGHMay 7, 2025

Medtronic MiniMed Recalls 1,440 Simplera Sensor Units Over Label Adhesion Risk (2025)

Medtronic MiniMed recalled 1,440 Simplera Sensor units distributed outside the United States after a device cap label may not adhere, risking sterility. The defect could increase infection risk. Patients and healthcare providers should stop using the device and follow recall instructions provided by Medtronic MiniMed or their healthcare provider.

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

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

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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.

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

1,440 units recalled
REF: MMT-5100JD1
European distribution in 6 countries
Label adhesion defect risks sterility and infection
Status: ACTIVE

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeCGM Sensor

Product Details

Brand

Medtronic MiniMed

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