# FDA recall Z-1607-2021

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

## Product

Medtronic REF: MMT-7020C1 Guardian Sensor (3)  for the following packaging:     GS3 5PK OUS1/ GTIN:  20643169704071  GS3 5PK 9L OUS1/ GTIN:  20763000243320  GS3 5PK 9L OUS1/ GTIN:  20763000318844  Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.      *Product not distributed within US.

## 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-1607-2021
- **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-1607-2021

## Citation

> AI Analytics. FDA recall Z-1607-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1607-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*