Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1009-2019·Announced 2019-03-20

Olympus PCF-Q180AC Video Colonoscope Recalled Due to Adhesive Error

Olympus is recalling two video colonoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the durability of the repair.

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 agency classified this as a Class II recall. The source text explicitly states that the effect of the defect is unknown and does not report any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Olympus Corporation of the Americas is recalling two units of the PCF-Q180AC Video Colonoscope. These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

The recall was initiated because the adhesive used in the repair of the endoscopes 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 affected units, identified by serial numbers 2501374 and 2704914, were distributed nationwide in the states of Connecticut, Illinois, Minnesota, Missouri, and North Carolina.

The recalled product

Product: Olympus PCF-Q180AC Video Colonoscope - 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
adhesive-error
Affected units: 2

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 2501374 and 2704914

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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