FDA recall Z-0033-2026

Medtronic MiniMed, Inc. · Class II · device

Product

Medtronic, Simplera Sensor, REF: MMT-5100JD1

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

Key facts

Status
Ongoing
Initiation date
2025-05-07
Report date
2025-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2026