No image published for this recall

Imager ii angiographic catheters m001314001 imager ii 5 st 65 038 bx5; m001314011 imager ii 5 st 100 038 bx5; m001314021 imager

Official notice

30 Sept 2026

Last checked

6 Oct 2026

CriticalFDA

An official FDA notice concerns Boston Scientific. The notice reports an injury risk. Stop using the product and follow the official notice. Published 2026-09-30. Recall numbers: Z-3214-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

262,686

Recall number

Z-3214-2026

Official notice

2026-09-30

The hazard

Injury 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 08714729354826, UDI-DI 08714729354833, UDI-DI 08714729354840, UDI-DI 08714729354857, UDI-DI 08714729354864, UDI-DI 08714729354871, UDI-DI 08714729354888, UDI-DI 08714729354901, UDI-DI 08714729354925, UDI-DI 08714729354963, UDI-DI 08714729354970, UDI-DI 08714729355120, UDI-DI 08714729355144, UDI-DI 08714729355168, UDI-DI 08714729355175, UDI-DI 08714729355182, UDI-DI 08714729355342, UDI-DI 08714729355403, UDI-DI 08714729355441, UDI-DI 08714729355489, UDI-DI 08714729355496, UDI-DI 08714729355588, UDI-DI 08714729355595, UDI-DI 08714729355649, UDI-DI 08714729355687, UDI-DI 08714729355700

Event Ids

99687

Recall Numbers

Z-3214-2026

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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

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

BG · Bulgaria

Affected area 8

BR · Brazil

Affected area 9

CA · Canada

Affected area 10

CH · Switzerland

Affected area 11

CL · Chile

Affected area 12

CN · China

Affected area 13

CO · Colombia

Affected area 14

CY · Cyprus

Affected area 15

CZ · Czech Republic

Affected area 16

DE · Germany

Affected area 17

DK · Denmark

Affected area 18

EG · Egypt

Affected area 19

ES · Spain

Affected area 20

FR · France

Affected area 21

GB · United Kingdom

Affected area 22

GR · Greece

Affected area 23

GT · Guatemala

Affected area 24

HK · Hong Kong

Affected area 25

HR · Croatia

Affected area 26

HU · Hungary

Affected area 27

IE · Ireland

Affected area 28

IL · Israel

Affected area 29

IT · Italy

Affected area 30

JO · Jordan

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

PK · Pakistan

Affected area 43

PL · Poland

Affected area 44

PT · Portugal

Affected area 45

RO · Romania

Affected area 46

RS · Serbia

Affected area 47

SA · Saudi Arabia

Affected area 48

SE · Sweden

Affected area 49

SG · Singapore

Affected area 50

SI · Slovenia

Affected area 51

SK · Slovakia

Affected area 52

SV · El Salvador

Affected area 53

TH · Thailand

Affected area 54

UA · Ukraine

Affected area 55

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific. Contact: Boston Scientific Corporation.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-3214-2026

Event id

99687

Units affected

262,686

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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