Guardian 4 Glucose Sensor — Class II medical device recall Z-1005-2024
Ongoing recall by Medtronic MiniMed, Inc., reported 2024-02-14, distributed nationwide. Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-
| Recall number | Z-1005-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IN, IS, IT, KW, LU, NL, NO, PL, PT, RO, SA, SE, SI |
| Quantity | 114,758 |
| UPC / GTIN / UDI-DI | 00763000413392, 00763000413484, 00763000413491, 00763000555276, 00763000555313, 00763000555320, 00763000712471, 20763000413389, 20763000413396, 20763000519692, 20763000555270, 20763000555287, 20763000555294, 20763000555317, 20763000555324, 20763000555331, 20763000712475 |
| Lot numbers | 00763000712471/F1323, 20763000555317/HG6WT9A, 763000555320/HG6WT9A, F1923, G0323, G1723, G2023, G2623, G2923, HG6RV7S, HG6RXB5, HG6T4T7, HG6T8RV, HG6TGNU, HG6TJ2Y, HG6TW97, HG6TWVU, HG6UNF2, HG6V7VV, HG6V8NN, HG6VB8S, HG6VNX3, HG6WKZU, HG6WLKS, HG6WNE1, HG6WUGE, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6XQCG, HG6XZJX, HG6Y0W1, HG6Y3QN, HG6Y5C6, HG6YEK6, HG6YFAF, HG6YFHL, HG6YJAR, HG6YJBD and 60 more |
| Model numbers | MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3 |
Product
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
Reason for recall
Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.
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-1005-2024. 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.