CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
InPen smart insulin pen recalled by Medtronic MiniMed
Medtronic MiniMed is recalling InPen smart insulin pen, distributed in 41 states. The recall was initiated on 4 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1650-2025
- FDA event ID
- 96421
- Recalling firm
- Medtronic MiniMed, Northridge, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2025
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 4 Mar 2025 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +48 days |
| 30 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Where it was distributed
US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontana
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
REF/UDI-DI(GTIN)/Lot: MMT-105NNBLNA/763000827182/D0020, D0034, D0036, D0038, D0045, D0046, D0050, D0057; MMT-105NNGYNA/763000827199/D0026, D0037, D0039, D0041, D0042, D0043, D0049; MMT-105NNPKNA/763000827205/D0029, D0030, D0040, D0051, D0062; MMT-105ELBLNA/763000827151/D0021, D0033, D0035, D0044, D0059, D0060, D0061; MMT-105ELGYNA/763000827168/D0031, D0032, D0047, D0068; MMT105ELPKNA/763000827175/D0027, D0028, D0048
Where was it sold?
US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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