Data Foundry

Medical device recalls 2021

Medtronic REF: MMT-7020LA — Class II medical device recall Z-1604-2021

Ongoing recall by Medtronic Inc., reported 2021-05-26. Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug cou

Recall numberZ-1604-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedtronic Inc., Northridge, CA, United States
Recall initiated2021-02-26
Classified2021-05-17
Reported by FDA2021-05-26
Quantity37,228 units
UPC / GTIN / UDI-DI20763000336985
Model numbersMMT-7020LA

Product

Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 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.

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-1604-2021. 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.