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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Medtronic InPen Smart Insulin Pens Recalled for Assembly Defect

Agency Publication Date: April 21, 2025
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Summary

Medtronic MiniMed, Inc. is recalling 8,986 InPen smart insulin pens due to a manufacturing defect where the pens were incorrectly assembled. This issue can prevent the insulin cartridge from fitting into the holder or make it very difficult to remove the cartridge holder from the pen. If you cannot use the device and do not have a backup insulin delivery method available, you may experience high blood sugar (hyperglycemia).

Risk

The incorrect assembly of the insulin pen prevents proper use of the device, which can lead to delayed or missed insulin doses. While no injuries have been reported to date, this defect may cause temporary hyperglycemia, a condition that can be serious if not addressed promptly with backup insulin.

What You Should Do

  1. This recall affects Medtronic InPen smart insulin pens in Blue, Grey, and Pink colors, including models MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, and MMT105ELPKNA.
  2. Check the model (REF) number and lot number located on your insulin pen or its original packaging to see if your device is included in the recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Medtronic MiniMed, Inc. for further instructions.
  4. Ensure you have a backup insulin delivery method, such as a manual insulin pen or syringes, immediately available in case your InPen fails to operate correctly.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: InPen smart insulin pen
Variants: Blue, Grey, Pink
Model / REF:
MMT-105NNBLNA
MMT-105NNGYNA
MMT-105NNPKNA
MMT-105ELBLNA
MMT-105ELGYNA
MMT105ELPKNA
Lot Numbers:
D0020
D0034
D0036
D0038
D0045
D0046
D0050
D0057
D0026
D0037
D0039
D0041
D0042
D0043
D0049
D0029
D0030
D0040
D0051
D0062
D0021
D0033
D0035
D0044
D0059
D0060
D0061
D0031
D0032
D0047
D0068
D0027
D0028
D0048
GTIN:
763000827182
763000827199
763000827205
763000827151
763000827168
763000827175

Recall #: Z-1650-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96421
Status: Active
Manufacturer: Medtronic MiniMed, Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 8,986
Distributed To: Oklahoma, Iowa, North Carolina, South Carolina, Michigan, Minnesota, California, Arizona, Alabama, Missouri, Washington, Illinois, Kansas, Texas, Florida, Montana, Maryland, Ohio, Virginia, New York, Tennessee, Hawaii, Massachusetts, New Jersey, Pennsylvania, Colorado, Wisconsin, Georgia, Connecticut, Nebraska, Oregon, Louisiana, New Mexico, South Dakota, North Dakota, Indiana, Nevada, West Virginia, Rhode Island, Arkansas, New Hampshire

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.