CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report

Gif-h190, Evis Exera Iii Gastrointestinal Videoscope recalled

Aizu Olympus is recalling Gif-h190, Evis Exera Iii Gastrointestinal Videoscope, distributed in Florida, Kentucky, Massachusetts, New Jersey, New York, Pennsylvania. The recall was initiated on 16 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 04953170305290 Serial Numbers 2515895, 2312905, 2628532

Quantity recalled24 incorrectly repaired 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-0416-2024
FDA event ID: 93335
Recalling firm: Aizu Olympus, Aizuwakamatsu
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2023
FDA classified: 29 Nov 2023
Reported: 6 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Oct 2023	Recall initiated by company
29 Nov 2023	Classified by FDA	+44 days
6 Dec 2023	Published in enforcement report	+7 days

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

Reason for recall

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Product as listed by the FDA

GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Where it was distributed

Domestic distribution to FL, KY, MA, NJ, NY, and PA

Florida Kentucky Massachusetts New Jersey New York Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 04953170305290 Serial Numbers 2515895, 2312905, 2628532

Where was it sold?

Domestic distribution to FL, KY, MA, NJ, NY, and PA

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.

Other products in this recall event

4 other products · FDA event 93335

This product is part of a recall event; the main page for the event is Pcf-h190l, Evis Exera Iii Colonovideoscope recalled by Aizu Olympus Co.

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023	CLASS II	Pcf-h190l, Evis Exera Iii Colonovideoscope recalled by Aizu Olympus Co	Aizu Olympus	Other	6 states
6 Dec 2023	CLASS II	Pcf-h190dl, Evis Exera Iii Colonovideoscope recalled by Aizu Olympus Co	Aizu Olympus	Other	6 states
6 Dec 2023	CLASS II	Cf-hq190l Evis Exera Iii Colonovideoscope recalled by Aizu Olympus Co	Aizu Olympus	Other	6 states
6 Dec 2023	CLASS II	Gif-hq190, Evis Exera Iii Gastrointestinal Videoscope recalled	Aizu Olympus	Other	6 states

More recalls from Aizu Olympus

All 31

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Olympus OER-Mini recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
10 Dec 2025Device	CLASS II	Olympus OER-Pro recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
10 Dec 2025Device	CLASS II	Olympus OER-Elite recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
6 Dec 2023Device	CLASS II	Gif-hq190, Evis Exera Iii Gastrointestinal Videoscope recalled	Aizu Olympus	Other	6 states
6 Dec 2023Device	CLASS II	Cf-hq190l Evis Exera Iii Colonovideoscope recalled by Aizu Olympus Co	Aizu Olympus	Other	6 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide