# FDA recall Z-0033-2026

> **Medtronic MiniMed, Inc.** · Class II · device recall initiated 2025-05-07.

## 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.

## Distribution

US: No distribution  OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom

## Key facts

- **Recall number:** Z-0033-2026
- **Recalling firm:** Medtronic MiniMed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2026

## Citation

> AI Analytics. FDA recall Z-0033-2026. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0033-2026. Source: US FDA. Licensed CC0.

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