Medtronic REF: MMT-7008B — Class II medical device recall Z-1600-2021
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-1600-2021 |
|---|---|
| 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 | 20,913 units |
| UPC / GTIN / UDI-DI | 00643169541719, 00643169786738, 00763000421304 |
| Model numbers | MMT-7008B |
Product
Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 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-1600-2021. 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.