Z-0033-2026 Class II Ongoing
FDA device recall Z-0033-2026 was initiated by Medtronic MiniMed, Inc. on May 7, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,440 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- May 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,440 units
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.
Distribution Pattern
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Code Information
Lot # HG81GLZ/ GTIN: 20763000649580