Medtronic MiniMed — Class II medical device recall Z-0108-2018
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-0108-2018 |
|---|---|
| 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 | 1,898,570 units |
| Lot numbers | 5168207, 5175824, 5175953, 5176442, 5178076, 5178077, 5178081, 5178084, 5179854, 5179855, 5179857, 5179975, 5179977, 5179979, 5181137, 5181138, 5181139, 5181140, 5181711, 5181712, 5181713, 5182176, 5182177, 5182179, 5182542, 5182543, 5182544, 5183072, 5183121, 5183122, 5183123, 5184087, 5184757, 5184758, 5185153, 5185154, 5185155, 5185156, 5185157, 5185471 and 68 more |
Product
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
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-0108-2018. 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.