HIGH

Medtronic Recalls Simplera Sensor Over Infection Risk

Medtronic recalled 1,440 Simplera Sensors on May 7, 2025. The device cap label may not adhere properly, compromising sterility and increasing infection risk. Patients should stop using the device immediately and contact their healthcare provider for instructions.

Quick Facts at a Glance

Recall Date
May 7, 2025
Hazard Level
HIGH
Brand
Medtronic MiniMed
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic MiniMed, Inc. or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled product is the Medtronic Simplera Sensor, REF: MMT-5100JD1, with Lot # HG81GLZ. It was distributed in Austria, Belgium, Italy, Spain, Switzerland, and the United Kingdom.

The Hazard

The device cap label may not adhere to the sensor. This defect compromises the sterility of the sensor and increases the risk of infection.

Reported Incidents

There are no reported incidents or injuries associated with this recall as of now. The classification of this recall is Class II, indicating a moderate risk.

What to Do

Stop using the device immediately. Follow the recall instructions provided by Medtronic. Contact Medtronic MiniMed, Inc. or your healthcare provider for further instructions.

Contact Information

For more details, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0033-2026.

Key Facts

  • Recall date: May 7, 2025
  • Quantity recalled: 1,440 units
  • Distribution: Austria, Belgium, Italy, Spain, Switzerland, UK
  • Class II recall

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot # HG81GLZ/ GTIN: 20763000649580
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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