Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1010-2019·Announced 2019-03-20

Olympus TJF-Q180V Duodenoscope Recalled Due to Adhesive Preparation Error

Olympus is recalling two TJF-Q180V duodenoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the device's durability or effectiveness.

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 contamination.

Plain-English summary

Olympus Corporation of the Americas is recalling two units of the Olympus TJF-Q180V Duodenoscope. These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. The specific units affected are identified by serial numbers 2506043 and 2619818.

The recall was initiated because the adhesive used in the repair of these 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 devices were distributed nationwide in the United States, specifically in the states of Connecticut, Illinois, Minnesota, Missouri, and North Carolina. Healthcare facilities and consumers should stop using these specific serial numbers and contact Olympus for further instructions.

The recalled product

Product: Olympus TJF-Q180V Duodenoscope - 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: 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 2506043 and 2619818

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

See all →

Moderate
Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
Moderate
Olympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
Moderate
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
Severe
Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30

Same hazard · defective repair