FDAHealthMay 7, 2025
Medtronic MiniMed, Inc. — Medtronic, Simplera Sensor, REF: MMT-5100JD1
⚠️ The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- May 7, 2025
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
What's affected?
- Product
- Medtronic, Simplera Sensor, REF: MMT-5100JD1
- Lot code
- HG81GLZ/
Additional details
Lot # HG81GLZ/ GTIN: 20763000649580
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,440 units.
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