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MINI InPen App, Model/CFN Number: MMT-8061 (Android Users) - safety alert

Official notice

24 Dec 2025

CriticalFDA

An official FDA notice concerns InPen App, Model/CFN Number: MMT-8061 (Android Users). The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2025-12-24. Recall numbers: Z-0958-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

8,251

Recall number

Z-0958-2026

Official notice

2025-12-24

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.

Other

UDI-DI 00763000974596

Event Ids

97904

Recall Numbers

Z-0958-2026

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Affected products

Product 1

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Units affected

8,251

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 · AK

Location 2

US · United States · AL

Location 3

US · United States · AR

Location 4

US · United States · AZ

Location 5

US · United States · CA

Location 6

US · United States · CO

Location 7

US · United States · CT

Location 8

US · United States · DE

Location 9

US · United States · FL

Location 10

US · United States · GA

Location 11

US · United States · HI

Location 12

US · United States · IA

Location 13

US · United States · ID

Location 14

US · United States · IL

Location 15

US · United States · IN

Location 16

US · United States · KS

Location 17

US · United States · KY

Location 18

US · United States · LA

Location 19

US · United States · MA

Location 20

US · United States · MD

Location 21

US · United States · ME

Location 22

US · United States · MI

Location 23

US · United States · MN

Location 24

US · United States · MO

Location 25

US · United States · MS

Location 26

US · United States · MT

Location 27

US · United States · NC

Location 28

US · United States · ND

Location 29

US · United States · NE

Location 30

US · United States · NH

Location 31

US · United States · NJ

Location 32

US · United States · NM

Location 33

US · United States · NV

Location 34

US · United States · NY

Location 35

US · United States · OH

Location 36

US · United States · OK

Location 37

US · United States · OR

Location 38

US · United States · PA

Location 39

US · United States · RI

Location 40

US · United States · SC

Location 41

US · United States · SD

Location 42

US · United States · TN

Location 43

US · United States · TX

Location 44

US · United States · UT

Location 45

US · United States · VA

Location 46

US · United States · VT

Location 47

US · United States · WA

Location 48

US · United States · WI

Location 49

US · United States · WV

Location 50

US · United States · WY

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

BE · Belgium

Affected area 4

CH · Switzerland

Affected area 5

CL · Chile

Affected area 6

CZ · Czech Republic

Affected area 7

DE · Germany

Affected area 8

DK · Denmark

Affected area 9

EE · Estonia

Affected area 10

EG · Egypt

Affected area 11

ES · Spain

Affected area 12

FI · Finland

Affected area 13

FR · France

Affected area 14

GB · United Kingdom

Affected area 15

GR · Greece

Affected area 16

HU · Hungary

Affected area 17

IE · Ireland

Affected area 18

IL · Israel

Affected area 19

IS · Iceland

Affected area 20

IT · Italy

Affected area 21

LU · Luxembourg

Affected area 22

NL · Netherlands

Affected area 23

NO · Norway

Affected area 24

PL · Poland

Affected area 25

PT · Portugal

Affected area 26

RO · Romania

Affected area 27

SE · Sweden

Affected area 28

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-0958-2026

Event id

97904

Units affected

8,251

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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