HIGH

Medtronic, Simplera Sensor, REF: MMT-5100JD1

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

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

Full Description

Medtronic, Simplera Sensor, REF: MMT-5100JD1. Reason: The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.. Classification: Class II. Quantity: 1,440 units. Distribution: US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom

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Product Classification

Product Details

Model Numbers
Lot # HG81GLZ/ GTIN: 20763000649580
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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