Use caution Medical device recall · FDA · Published March 4, 2025

Medtronic MiniMed InPen Smart Insulin Pen Recall: Incorrect Assembly Risk

Medtronic MiniMed recalls specific InPen smart insulin pens due to potential incorrect assembly causing insulin cartridge issues. Affected units may lead to temporary hyperglycemia without backup insulin.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1650-2025Medical device Medtronic MiniMed ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMedtronic MiniMed, Inc.18000 Devonshire St · Northridge, CA 91325-1219

✎ GovInfoNow plain-language explainer

Medtronic MiniMed is recalling certain InPen smart insulin pens that may have been incorrectly assembled. This could cause the insulin cartridge to not fit properly or be difficult to remove, potentially leading to temporary high blood sugar levels if backup insulin is unavailable. Read more at govinfonow.com/recall/52678-medtronic-minimed-inpen-smart-insulin-pen-recall-incorrect-assembly-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52678-medtronic-minimed-inpen-smart-insulin-pen-recall-incorrect-assembly-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1650-2025

Cite this page

“Medtronic MiniMed InPen Smart Insulin Pen Recall: Incorrect Assembly Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52678-medtronic-minimed-inpen-smart-insulin-pen-recall-incorrect-assembly-risk. Based on FDA recall #Z-1650-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1650-2025%22&limit=1).

The FDA announced on March 4, 2025, that Medtronic MiniMed is recalling InPen smart insulin pens due to potential assembly errors. The agency said the hazard involves cartridges not fitting or being difficult to remove, which could cause temporary hyperglycemia if no backup insulin is available.

How to tell if you have it

Brand: Medtronic MiniMed
Product: InPen smart insulin pen
REF codes: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Lot codes: D0020, D0021, D0026, D0027, D0028, D0029, D0030, D0031, 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
Units affected: 8,986

The hazard

The FDA said the insulin pens may have been incorrectly assembled. Users could experience issues where the insulin cartridge will not fit into the cartridge holder or the holder is difficult to remove from the pen. If the issue is present and the user does not have backup insulin, they may experience temporary hyperglycemia.

Context

GovInfoNow's records show Medtronic MiniMed has had 13 other recalls since November 15, 2023. Recent brand recalls include a July 13, 2026 recall of the 640G Insulin Pump for risk of incorrect delivery and a June 16, 2026 recall regarding the Go App version 1.0.0/1.1.0 potentially causing missed doses. Other recent recalls of similar products include an May 20, 2026 recall of Insulet Omnipod 5 Pods for insulin leak risk and an May 20, 2026 recall of Insulet Omnipod DASH Pods for insulin leaking risk.

How to tell if you have this one

Check for the model numbers: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, or MMT105ELPKNA. These pens were sold with specific lot numbers and reference codes listed in the recall notice.

Brand
Medtronic MiniMed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Pen Model
Identify your InPen smart insulin pen model by checking the reference code on the pen or its packaging.
Contact Manufacturer
Reach out to Medtronic MiniMed directly for guidance on whether your pen is affected and what steps to take next.

Where it went and when

Where it was distributed

Distributed in 41 states.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 57 days after the firm started it.

Mar 4, 2025Firm started the recall
Apr 21, 2025FDA classified it Class II
Apr 30, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Medtronic MiniMed recalls

Keep exploring

More Medtronic MiniMed recalls

Link to this recall

<a href="https://govinfonow.com/recall/52678-medtronic-minimed-inpen-smart-insulin-pen-recall-incorrect-assembly-risk">Medtronic MiniMed InPen Smart Insulin Pen Recall: Incorrect Assembly Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1650-2025 (March 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1650-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.