CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Evis Exera Iii Gastrointestinal Videoscope recalled

Olympus Corporation of the Americas is recalling Evis Exera Iii Gastrointestinal Videoscope, distributed nationwide in the US. The recall was initiated on 2 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.

Quantity recalled1687 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0288-2024
FDA event ID: 93212
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Oct 2023
FDA classified: 9 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Reason category: Sterility
Device type: Other Medical Devices

Timeline

2 Oct 2023	Recall initiated by company
9 Nov 2023	Classified by FDA	+38 days
15 Nov 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

EVIS EXERA III Gastrointestinal Videoscope

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

Which lots are affected?

Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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