Medical device recalls Moderate risk

Medtronic MiniMed, Inc. recalls Medtronic, Simplera Sensor, REF: MMT-5100JD1

Recall date
May 7, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0033-2026
FDA classification
Class II
Brand / firm
Medtronic MiniMed, Inc.
Sold / distributed
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic, Simplera Sensor, REF: MMT-5100JD1

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