Z-1650-2025Class II

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

Name: Z-1650-2025 InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA...
Creator: Medtronic MiniMed, Inc.
Published: 2025-03-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-03-04 / Open, Classified

FDA source

Medtronic MiniMed, Inc. began a recall of InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA on 2025-03-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1650-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-04
Posted: 2025-04-21
Recalling firm: Medtronic, Inc.
Product: InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Product code: FMF Syringe, Piston
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.
FDA root cause: Mixed-up of materials/components
Action: On 3/4/2025, correction notices were sent to customers and distributors informing them of the following: 1) If you have already inserted your insulin cartridge into your device without difficulty removing the cartridge holder, then you can continue normal use. 2) If you have a device from one of the affected lot numbers and have not yet started using it, or have had difficulties in removing the cartridge holder or inserting the insulin cartridge, please call 1-800-646-4633, option 1, or go to https://info.medtronicdiabetes.com/ICH-replacement-form to request a replacement product. Do not use this device and dispose of it according to local regulations. 3) Complete and return the confirmation form via link: https://info.medtronicdiabetes.com/cartridge-holder Distributors are asked to notify impacted customers. If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1650-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1650-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21

Product code FMF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)