Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1008-2019·Announced 2019-03-20

Olympus GIF-H180J Gastrointestinal Videoscope Recalled Due to Adhesive Error

Olympus is recalling one GIF-H180J videoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the source text explicitly states that the effect of the defect is unknown and no injuries or illnesses are reported, fitting the criteria for a voluntary precautionary recall or low-risk defect.

Plain-English summary

Olympus Corporation of the Americas is recalling one unit of the GIF-H180J Gastrointestinal Videoscope. The device is intended for endoscopic diagnosis and treatment within the gastrointestinal tract. The recall is limited to a specific unit with Serial Number 2418319.

The recall was initiated because the adhesive used during the repair of the endoscope was incorrectly prepared. It is currently unknown what effect this nonconforming adhesive mixture will have on the durability or effectiveness of the gluing operation for the endoscope repair.

The affected unit was distributed in the United States in the states of Connecticut, Illinois, Minnesota, Missouri, and North Carolina. Consumers and healthcare facilities should stop using the affected device and contact Olympus Corporation of the Americas for instructions on how to proceed.

The recalled product

Product: Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope
Hazard: defective-repair
device-failure
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 2418319

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 →

Same manufacturer · Olympus Corporation of the Americas

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