Class II — Medtronic MiniMed, Inc.
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. |
| Product | Medtronic, Simplera Sensor, REF: MMT-5100JD1 |
| Quantity | 1,440 units |
| Distribution | US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom |
| Initiated | 2025-05-07 |
| Classified | 2025-10-02 |
| Recall number | Z-0033-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic MiniMed, Inc. (Z-0033-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96745/
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