The Recall Desk
ModerateFDA (Devices)·Z-1007-2019·Announced 2019-03-20

Olympus Ultrasound Gastrovideoscope Recalled Due to Adhesive Preparation Error

Olympus is recalling one ultrasound gastrovideoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the effect of the defect is unknown, indicating a theoretical risk rather than reported injuries or illnesses.

Plain-English summary

Olympus Corporation of the Americas is recalling one Olympus GF-UCT180 Ultrasound Gastrovideoscope. The device is intended for endoscopic diagnosis and treatment within the gastrointestinal tract. The recall was initiated because the adhesive used in the repair of the endoscope was incorrectly prepared.

It is currently unknown what effect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. The recall involves a single unit with Serial Number 7621683.

The device was distributed in the United States in the states of Connecticut, Illinois, Minnesota, Missouri, and North Carolina. Consumers and healthcare facilities should contact Olympus Corporation of the Americas for further instructions regarding the recall.

The recalled product

Product
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number 7621683

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →