Recall Z-0033-2026— Medtronic MiniMed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2025-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic, Simplera Sensor, REF: MMT-5100JD1. Reason: The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection..
- Recalling firm
- Medtronic MiniMed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-07
- Firm location
- Northridge, CA, United States
Product description
Medtronic, Simplera Sensor, REF: MMT-5100JD1
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.