Medtronic MiniMed, Inc. recalls Medtronic

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0033-2026
• FDA device classification · MDSOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic MiniMed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.