Medtronic MiniMed — Class II medical device recall Z-0111-2018
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-0111-2018 |
|---|---|
| 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 | 5,842 units |
| Lot numbers | 6207537, 6211649 |
Product
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
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-0111-2018. 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.