CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report

Olympus GIF-H180J Gastrointestinal Videoscope recalled

Olympus Corporation of the Americas is recalling Olympus GIF-H180J Gastrointestinal Videoscope, distributed nationwide in the US. The recall was initiated on 17 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 2418319

Quantity recalled1

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-1008-2019
FDA event ID: 82099
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 17 Dec 2018
FDA classified: 12 Mar 2019
Reported: 20 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

17 Dec 2018	Recall initiated by company
12 Mar 2019	Classified by FDA	+85 days
20 Mar 2019	Published in enforcement report	+8 days

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

Reason for recall

The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.

Product as listed by the FDA

Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Where it was distributed

US Nationwide distribution in the states of CT, IL, MN, MO, and NC.

Nationwide Connecticut Illinois Minnesota Missouri North Carolina

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number 2418319

Where was it sold?

US Nationwide distribution in the states of CT, IL, MN, MO, and NC.

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 21 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

3 other products · FDA event 82099

This product is part of a recall event; the main page for the event is Olympus PCF-Q180AC Video Colonoscope recalled.

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019	CLASS II	Olympus PCF-Q180AC Video Colonoscope recalled	Olympus Corporation of the Americas	Other	Nationwide
20 Mar 2019	CLASS II	Olympus TJF-Q180V Duodenoscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
20 Mar 2019	CLASS II	Olympus GF-UCT180 Ultrasound Gastrovideoscope recalled	Olympus Corporation of the Americas	Other	Nationwide

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