Health product recall

Smartpill Smartbar

Last updated

Summary

Product
Smartpill Smartbar
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Smartpill Smartbar

73614B

FGS-0505

Issue

The Smartbar has the potential to be contaminated with tobacco beetles (lasioderma serricorne). This contamination may lead to patient nausea, emotional changes, or a delay in the procedure which could lead to a delay in diagnosis.

Recall start date: February 8, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Given Imaging, Inc.

15 Hampshire Street, Mansfield, Massachusetts, United States, 02048

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72931

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