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.
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, 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.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- 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
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.
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