No image published for this recall

Vizishot 2 flex

Official notice

4 Feb 2026

MediumHealth Canada

An official Health Canada notice concerns Vizishot 2 flex. Olympus is removing all unexpired ViziShot 2 Flex (19g) devices due to a potential patient safety issue. Customers should not use any of the affected devices listed in the medical device recall letter and should return any affected products. Olympus is also reinforcing existing warnings in the Instructions for Use (IFU). Published 2026-02-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77960

Official notice

2026-02-04

The hazard

Olympus is removing all unexpired ViziShot 2 Flex (19g) devices due to a potential patient safety issue. Customers should not use any of the affected devices listed in the medical device recall letter and should return any affected products. Olympus is also reinforcing existing warnings in the Instructions for Use (IFU).

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.

Skus

NA-U403SX-4019

Other

RA RA-77960

Model Numbers

NA-U403SX-4019

Recall Numbers

77960

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Affected products

Product 1

Affected products - ViziShot 2 Flex, Lot or serial number - All unexpired lots., Model or catalogue number - NA-U403SX-4019

Product 2

Lot or serial number - All unexpired lots., Model or catalogue number - NA-U403SX-4019

Risk / hazard

Olympus is removing all unexpired ViziShot 2 Flex (19g) devices due to a potential patient safety issue. Customers should not use any of the affected devices listed in the medical device recall letter and should return any affected products. Olympus is also reinforcing existing warnings in the Instructions for Use (IFU).

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77960

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

HOME
Medium

Gyrus acmi® classic series continuous flow resectoscope

Health Canada22 Jun 2026

Brand match

Medium risk

Markets

CA
HOME
Medium

Shockpulse-se lithotripsy system and shockpulse lithotripsy generator

Health Canada29 Jan 2026

Brand match

Medium risk

Markets

CA
HOME
Medium

Shockpulse lithotripsy system, generator and transducer

Health Canada31 Dec 2025

Brand match

Medium risk

Markets

CA
HOME
Medium

Shockpulse lithotripsy transducer

Health Canada24 Oct 2025

Brand match

Medium risk

Markets

CA
HOME
Critical

Uropass ureteral access sheath

Health Canada18 Oct 2024

Brand match

Critical risk

Markets

CA
HOME
Medium

Instaclear sheath

Health Canada17 May 2024

Brand match

Medium risk

Markets

CA
HOME
Medium

Powerseal curved jaw sealer & divider double action

Health Canada17 Apr 2024

Brand match

Medium risk

Markets

CA
HOME
Medium

Ezdilate balloon dilators

Health Canada4 Dec 2023

Brand match

Medium risk

Markets

CA
HOME
Medium

Ezdilate™ balloon dilator (wg)

Health Canada25 Sept 2024

Brand match

Medium risk

Markets

CA
HOME
Critical

Everest cutting forceps

Health Canada18 Sept 2024

Brand match

Critical risk

Markets

CA
HOME
Medium

Uropass ureteral access sheath

Health Canada19 Jun 2023

Brand match

Medium risk

Markets

CA
HOME
Medium

Powerseal curved jaw sealer & divider double action

Health Canada22 Aug 2022

Brand match

Medium risk

Markets

CA

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 4 Feb 2026. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.