FDA Device Recall Z-0033-2026: Medtronic MiniMed, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2026.

Recall Res Number

Z-0033-2026

Recalling Firm / Manufacturer

Medtronic MiniMed, Inc.

FEI Number

3003166194

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-05-07

Date Posted

2025-10-02

Date Terminated

N/A

Product Code

MDS

Event Number

96745

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.

Action Details 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.

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

Code Information / Serial Numbers Lot # HG81GLZ/ GTIN: 20763000649580

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Medical Device Recall: Z-0033-2026

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer