Class II

Medical Device Recall: Medtronic, Simplera Sensor, REF: MMT-5100JD1

Medtronic MiniMed, Inc. · May 7, 2025

Reason for Recall

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

Distribution

US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom

Quantity Affected

1,440 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0033-2026

Status: ongoing

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