Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Guardian 4 Glucose Sensor Recalled by Medtronic MiniMed, Inc. Due to Some sensors may have a glucose oxidase (GOX)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic MiniMed, Inc. directly.
Affected Products
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
Quantity: 114,758
Why Was This Recalled?
Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic MiniMed, Inc.
Medtronic MiniMed, Inc. has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report