FDA Enforcement
Class II
Ongoing
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Recall: Z-0033-2026
·
Reported October 8, 2025
Enforcement
- Recall Number
- Z-0033-2026
- Event ID
- 96745
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic MiniMed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 8, 2025
- Initiation Date
- May 7, 2025
- Classification Date
- October 2, 2025
- Address
- 18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States
Description
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Reason
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Code Info
Lot # HG81GLZ/ GTIN: 20763000649580
Distribution
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Quantity
1,440 units