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Open, Classified

Medtronic, Simplera Sensor, REF: MMT-5100JD1

FDA Recall Z-0033-2026 · Posted 2025-10-02

Recalling FirmMedtronic MiniMed, Inc.
Recall StatusOpen, Classified
Product CodeMDS
Date Initiated2025-05-07
Product Quantity1,440 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.

Firm 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.

Root Cause

Process design

Distribution Pattern

US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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