Medtronic — Class II medical device recall Z-0033-2026
Ongoing recall by Medtronic MiniMed, Inc., reported 2025-10-08. The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing th
| Recall number | Z-0033-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2025-05-07 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Countries outside the US | AT, BE, CH, ES, GB, IT |
| Quantity | 1,440 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 20763000649580 |
| Lot numbers | HG81GLZ |
| Model numbers | MMT-5100JD1 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0033-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.