InPen smart insulin pen — Class II medical device recall Z-1650-2025
Ongoing recall by Medtronic MiniMed, Inc., reported 2025-04-30, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Insulin pens may have been incorrectly assembled therefore users could experience the following: either the in
| Recall number | Z-1650-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2025-03-04 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV |
| Quantity | 8,986 |
| UPC / GTIN / UDI-DI | 00763000827151, 00763000827168, 00763000827175, 00763000827182, 00763000827199, 00763000827205 |
| Lot numbers | D0028, D0030, D0032, D0033, D0034, D0035, D0036, D0037, D0038, D0039, D0040, D0041, D0042, D0043, D0044, D0045, D0046, D0047, D0048, D0049, D0050, D0051, D0057, D0059, D0060, D0061, D0062, D0068 |
| Model numbers | MMT-105ELBLNA, MMT-105ELGYNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT105ELPKNA |
Product
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Reason for recall
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary 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-1650-2025. 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.