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MINI CareLink Clinic, REF: MMT-7350 - safety alert

Official notice

3 Dec 2025

CriticalFDA

An official FDA notice concerns CareLink Clinic, REF: MMT-7350. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2025-12-03. Recall numbers: Z-0594-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

12,126

Recall number

Z-0594-2026

Official notice

2025-12-03

The hazard

Chemical exposure 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.

Event Ids

97873

Recall Numbers

Z-0594-2026

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Affected products

Product 1

CareLink Clinic, REF: MMT-7350

Units affected

12,126

Risk / hazard

Chemical exposure 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

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

AU · Australia

Affected area 6

BE · Belgium

Affected area 7

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CL · Chile

Affected area 11

CO · Colombia

Affected area 12

CY · Cyprus

Affected area 13

CZ · Czech Republic

Affected area 14

DE · Germany

Affected area 15

DK · Denmark

Affected area 16

EE · Estonia

Affected area 17

EG · Egypt

Affected area 18

ES · Spain

Affected area 19

FI · Finland

Affected area 20

FR · France

Affected area 21

GB · United Kingdom

Affected area 22

GR · Greece

Affected area 23

HK · Hong Kong

Affected area 24

HR · Croatia

Affected area 25

HU · Hungary

Affected area 26

IE · Ireland

Affected area 27

IL · Israel

Affected area 28

IN · India

Affected area 29

IS · Iceland

Affected area 30

IT · Italy

Affected area 31

JP · Japan

Affected area 32

KR · South Korea

Affected area 33

KW · Kuwait

Affected area 34

LT · Lithuania

Affected area 35

LU · Luxembourg

Affected area 36

LV · Latvia

Affected area 37

MX · Mexico

Affected area 38

MY · Malaysia

Affected area 39

NL · Netherlands

Affected area 40

NO · Norway

Affected area 41

NZ · New Zealand

Affected area 42

PL · Poland

Affected area 43

PT · Portugal

Affected area 44

RO · Romania

Affected area 45

RU · Russia

Affected area 46

SE · Sweden

Affected area 47

SG · Singapore

Affected area 48

SK · Slovakia

Affected area 49

TH · Thailand

Affected area 50

TR · Turkey

Affected area 51

TW · Taiwan

Affected area 52

UA · Ukraine

Affected area 53

UY · Uruguay

Affected area 54

ZA · South Africa

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

critical

Recall details

Recall number

Z-0594-2026

Event id

97873

Units affected

12,126

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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