Recall archive / FDA device enforcement
Medtronic, Simplera Sensor, REF: MMT-5100JD1 — FDA record Z-0033-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic MiniMed, Inc.
- Quantity
- 1,440 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0033-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # HG81GLZ/ GTIN: 20763000649580 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 8, 2025
- Recall initiation date
- May 7, 2025
- Center classification date
- Oct 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.