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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/Monitoring Devices

Medtronic Simplera Sensor Recalled for Sterility Issues and Infection Risk

Agency Publication Date: October 2, 2025
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Summary

Medtronic MiniMed, Inc. is recalling 1,440 Simplera Sensors (model MMT-5100JD1) because the device cap label may not adhere properly to the sensor. This defect can compromise the sensor's sterility, exposing the user to a potential risk of infection. No incidents or injuries have been reported to date regarding this issue.

Risk

If the cap label fails to stick, the sensor is no longer maintained in a sterile environment. Using a non-sterile sensor increases the risk of developing an infection at the site where the sensor is inserted into the body.

What You Should Do

  1. This recall affects Medtronic Simplera Sensors with model number (REF) MMT-5100JD1 and lot number HG81GLZ.
  2. Check the label on your sensor packaging for lot number HG81GLZ or GTIN 20763000649580 to determine if your device is affected.
  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. Call the FDA at 1-888-463-6332 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: Medtronic Simplera Sensor
Model / REF:
MMT-5100JD1
Lot Numbers:
HG81GLZ
GTIN:
20763000649580

Quantity: 1,440 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96745
Status: Active
Manufacturer: Medtronic MiniMed, Inc.
Sold By: authorized dealers
Manufactured In: United States
Units Affected: 1,440 units

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.