Medtronic recalled 1,440 Simplera Sensors on May 7, 2025. The device cap label may not adhere properly, compromising sterility and increasing infection risk. Patients should stop using the device immediately and contact their healthcare provider for instructions.
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
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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The recalled product is the Medtronic Simplera Sensor, REF: MMT-5100JD1, with Lot # HG81GLZ. It was distributed in Austria, Belgium, Italy, Spain, Switzerland, and the United Kingdom.
The device cap label may not adhere to the sensor. This defect compromises the sterility of the sensor and increases the risk of infection.
There are no reported incidents or injuries associated with this recall as of now. The classification of this recall is Class II, indicating a moderate risk.
Stop using the device immediately. Follow the recall instructions provided by Medtronic. Contact Medtronic MiniMed, Inc. or your healthcare provider for further instructions.
For more details, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0033-2026.
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