Summary
The FDA issued a Class II for Medtronic, Simplera Sensor, REF: MMT-5100JD1 by Medtronic MiniMed, Inc.. Reason: The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection..
Details
Source
Device Recall
External ID
Z-0033-2026
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Lot/Code Info: Lot # HG81GLZ/ GTIN: 20763000649580
Quantity Affected: 1,440 units
Reason for Recall
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Distribution
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-07
Company
Northridge, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic MiniMed, Inc. has 43 FDA actions in our database, including 37 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic MiniMed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic MiniMed, Inc. have FDA actions?
Medtronic MiniMed, Inc. has 43 FDA actions in our database, including 37 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0033-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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