Medtronic, Simplera Sensor, REF: MMT-5100JD1
FDA device recall Z-0033-2026 · posted 2025-10-02 · Open, Classified
Recall details
- Recalling firm
- Medtronic MiniMed, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MDS
- Quantity affected
- 1,440 units
- Distribution
- US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
- Date initiated
- 2025-05-07
- Date posted
- 2025-10-02
- Location
- Northridge, CA
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