Medtronic MiniMed, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0033-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Product Classification:

Class II

Date Initiated: May 7, 2025

Date Posted: October 8, 2025

Recall Number: Z-0033-2026

Event ID: 96745

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.

Status: Ongoing

Product Quantity: 1,440 units

Code Information:

Lot # HG81GLZ/ GTIN: 20763000649580

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated