PlainRecalls
FDA Devices Moderate Class II Ongoing

InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

Reported: April 30, 2025 Initiated: March 4, 2025 #Z-1650-2025

Product Description

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.

Details

Recalling Firm
Medtronic MiniMed, Inc.
Units Affected
8,986
Distribution
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
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA. Recalled by Medtronic MiniMed, Inc.. Units affected: 8,986.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1650-2025.