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MINI - safety alert

Official notice

16 Nov 2022

CriticalFDA

An official FDA notice concerns MINI. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2022-11-16. Recall numbers: Z-0193-2023. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

399,651

Recall number

Z-0193-2023

Official notice

2022-11-16

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

90910

Recall Numbers

Z-0193-2023

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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 · DC

Location 9

US · United States · DE

Location 10

US · United States · FL

Location 11

US · United States · GA

Location 12

US · United States · HI

Location 13

US · United States · IA

Location 14

US · United States · ID

Location 15

US · United States · IL

Location 16

US · United States · IN

Location 17

US · United States · KS

Location 18

US · United States · KY

Location 19

US · United States · LA

Location 20

US · United States · MA

Location 21

US · United States · MD

Location 22

US · United States · ME

Location 23

US · United States · MI

Location 24

US · United States · MN

Location 25

US · United States · MO

Location 26

US · United States · MS

Location 27

US · United States · MT

Location 28

US · United States · NC

Location 29

US · United States · ND

Location 30

US · United States · NE

Location 31

US · United States · NH

Location 32

US · United States · NJ

Location 33

US · United States · NM

Location 34

US · United States · NV

Location 35

US · United States · NY

Location 36

US · United States · OH

Location 37

US · United States · OK

Location 38

US · United States · OR

Location 39

US · United States · PA

Location 40

US · United States · RI

Location 41

US · United States · SC

Location 42

US · United States · SD

Location 43

US · United States · TN

Location 44

US · United States · TX

Location 45

US · United States · UT

Location 46

US · United States · VA

Location 47

US · United States · VT

Location 48

US · United States · WA

Location 49

US · United States · WI

Location 50

US · United States · WV

Location 51

US · United States · WY

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

AU · Australia

Affected area 4

BE · Belgium

Affected area 5

CA · Canada

Affected area 6

CH · Switzerland

Affected area 7

CL · Chile

Affected area 8

CZ · Czech Republic

Affected area 9

DE · Germany

Affected area 10

DK · Denmark

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

GT · Guatemala

Affected area 17

HU · Hungary

Affected area 18

IE · Ireland

Affected area 19

IL · Israel

Affected area 20

IT · Italy

Affected area 21

LI · Liechtenstein

Affected area 22

LU · Luxembourg

Affected area 23

MX · Mexico

Affected area 24

NL · Netherlands

Affected area 25

NO · Norway

Affected area 26

NZ · New Zealand

Affected area 27

PE · Peru

Affected area 28

PL · Poland

Affected area 29

PT · Portugal

Affected area 30

RO · Romania

Affected area 31

SE · Sweden

Affected area 32

SK · Slovakia

Affected area 33

SV · El Salvador

Affected area 34

TR · Turkey

Affected area 35

VE · Venezuela

Affected area 36

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

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

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-0193-2023

Event id

90910

Units affected

399,651

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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