Z-0033-2026Class II

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Name: Z-0033-2026 Medtronic, Simplera Sensor, REF: MMT-5100JD1
Creator: Medtronic MiniMed, Inc.
Published: 2025-05-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-05-07 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic MiniMed, Inc. began a recall of Medtronic, Simplera Sensor, REF: MMT-5100JD1 on 2025-05-07. FDA classified it as Class II and gives the reason as "The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0033-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-07
Posted: 2025-10-02
Recalling firm: Medtronic, Inc.
Product: Medtronic, Simplera Sensor, REF: MMT-5100JD1
Product code: MDS Sensor, Glucose, Invasive
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 1,440 units
Distribution: US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Product codes and lots: Lot # HG81GLZ/ GTIN: 20763000649580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0033-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0033-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02

Product code MDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)