Medtronic MiniMed — Class II medical device recall Z-0109-2018
Ongoing recall by Medtronic Inc., reported 2017-11-29. Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
| Recall number | Z-0109-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2017-09-10 |
| Classified | 2017-11-18 |
| Reported by FDA | 2017-11-29 |
| Quantity | 2,163,610 units |
| Lot numbers | 5183060, 5183061, 5184968, 5185467, 5185468, 5185469, 5185470, 5185690, 5187300, 5187301, 5187556, 5187557, 5187558, 5187559, 5188321, 5188322, 5188323, 5188324, 5188325, 5188326, 5188327, 5188328, 5188329, 5188330, 5189051, 5189053, 5189054, 5189476, 5189477, 5189478, 5189521, 5189522, 5190185, 5190186, 5190187, 5190188, 5190189, 5191046, 5191047, 5191355 and 4 more |
Product
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
Reason for recall
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
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-0109-2018. 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.