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Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used

Official notice

16 Sept 2026

Last checked

22 Sept 2026

CriticalFDA

An official FDA notice concerns Given Imaging. The notice reports an injury risk. Stop using the product and follow the official notice. Published 2026-09-16. Recall numbers: Z-3090-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

127,416

Recall number

Z-3090-2026

Official notice

2026-09-16

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 07290101369707, UDI-DI 07290101369714

Event Ids

99626

Recall Numbers

Z-3090-2026

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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

BG · Bulgaria

Affected area 7

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CL · Chile

Affected area 11

CN · China

Affected area 12

CZ · Czech Republic

Affected area 13

DE · Germany

Affected area 14

DO · Dominican Republic

Affected area 15

ES · Spain

Affected area 16

FR · France

Affected area 17

GB · United Kingdom

Affected area 18

GR · Greece

Affected area 19

HK · Hong Kong

Affected area 20

IE · Ireland

Affected area 21

IL · Israel

Affected area 22

IN · India

Affected area 23

IT · Italy

Affected area 24

LU · Luxembourg

Affected area 25

NL · Netherlands

Affected area 26

NO · Norway

Affected area 27

NZ · New Zealand

Affected area 28

PL · Poland

Affected area 29

PT · Portugal

Affected area 30

SE · Sweden

Affected area 31

SG · Singapore

Affected area 32

TH · Thailand

Affected area 33

TW · Taiwan

Affected area 34

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Given Imaging. Contact: Given Imaging Ltd..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-3090-2026

Event id

99626

Units affected

127,416

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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