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MINI Medtronic, Simplera Sensor, REF: MMT-5100JD1 - safety alert

Official notice

8 Oct 2025

MediumFDA

An official FDA notice concerns Medtronic, Simplera Sensor, REF: MMT-5100JD1. The notice reports an infection risk. Stop using the product and follow the official notice. Published 2025-10-08. Lots: HG81GLZ/. Recall numbers: Z-0033-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,440

Recall number

Z-0033-2026

Official notice

2025-10-08

The hazard

Infection risk

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

HG81GLZ/

Event Ids

96745

Recall Numbers

Z-0033-2026

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Affected products

Product 1

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Units affected

1,440

Risk / hazard

Infection risk

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

BE · Belgium

Affected area 4

CH · Switzerland

Affected area 5

ES · Spain

Affected area 6

GB · United Kingdom

Affected area 7

IT · Italy

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: MINI, Medtronic Minimed. Contact: Medtronic MiniMed, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0033-2026

Event id

96745

Units affected

1,440

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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