Simplera Sensor (Medtronic) – Sterility Compromise (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Brand
Medtronic MiniMed, Inc.
Lot Codes / Batch Numbers
Lot # HG81GLZ/ GTIN: 20763000649580
Products Sold
Lot # HG81GLZ/ GTIN: 20763000649580
Medtronic MiniMed, Inc. is recalling Medtronic, Simplera Sensor, REF: MMT-5100JD1 due to The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Recommended Action
Per FDA guidance
On May 7, 2025, Medtronic issued a "Urgent Field Safety Notice" to affected consignees. Medtronic asked consignees to take the following actions: 1. Verify if the sensors you currently have are from the impacted lot. 2. If you have a Simplera" sensor from the impacted lot, do not use this Simplera" sensor and dispose of it according to local regulations. 3. Please contact our helpline/your Medtronic contact at 01923 205167 to request a replacement. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter, even if your sensor is unaffected, or if you do not have any sensors from the affected lot.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026