CareLink Clinic — Class II medical device recall Z-0594-2026
Ongoing recall by Medtronic MiniMed, Inc., reported 2025-12-03, distributed nationwide. Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potent
| Recall number | Z-0594-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2025-10-21 |
| Classified | 2025-11-25 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IQ, IS, IT, JP, KR, KW, LT, LU, LV, MX, MY, NL, NO, NZ, OM, PL, PT, QA, RO, RU, SE, SG, SK, TH, TR, TW, UA, UY, ZA |
| Quantity | 12,126 |
| Reason classes | software |
| Model numbers | MMT-7350 |
Product
CareLink Clinic, REF: MMT-7350
Reason for recall
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
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-0594-2026. 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.