# FDA recall Z-1599-2021

> **Medtronic Inc.** · Class II · device recall initiated 2021-02-26.

## Product

Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

## Reason for recall

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug  could result in inaccurate elevated sensor glucose readings.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1599-2021
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-26
- **Report date:** 2021-05-26

- **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-1599-2021

## Citation

> AI Analytics. FDA recall Z-1599-2021. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1599-2021. Source: US FDA. Licensed CC0.

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