FDAClass IIOctober 8, 2025

Medtronic recall: Sterility Concern

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Why was Medtronic recalled?

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # HG81GLZ/ GTIN: 20763000649580

Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Recalling firm
Medtronic MiniMed, Inc.
Quantity
1,440 units
Distribution
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Recall date
October 8, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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