FDAFDA · Food and drugs·Recall number Z-0033-2026
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Published October 8, 2025 · Recall initiated: May 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic MiniMed, Inc.
- Distributor
- US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
- Lot
- Lot # HG81GLZ/ GTIN: 20763000649580
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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