Medtronic REF: MMT-7020D1 Guardian Sensor — Class II medical device recall Z-1612-2021
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 number | Z-1612-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-05-17 |
| Reported by FDA | 2021-05-26 |
| Quantity | 111,678 units |
| UPC / GTIN / UDI-DI | 00643169704084, 00763000243333, 00763000318857 |
| Model numbers | MMT-7020D1 |
Product
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 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.
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-1612-2021. 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.