Olympus Recalls Gastrovideoscope Due to Insufficient Cleaning Accessory Information
Olympus is recalling 1,014 EVIS EXERA II Gastrovideoscopes because specific cleaning accessories required for reprocessing were not provided.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is insufficient information for cleaning accessories, which is a procedural and documentation issue rather than a direct structural defect or reported injury, aligning with the 'Moderate' criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,014 units of the EVIS EXERA II Gastrovideoscope (Model GF-UCT180). The recall was initiated because the manufacturer did not provide sufficient information regarding the specific cleaning accessories required for the cleaning and reprocessing of these ultrasound endoscopes.
The affected devices are distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities where these units are currently located. The recall number is Z-2818-2015.
Healthcare facilities and users should check their inventory for the affected serial numbers listed in the official recall notice. Users should stop using the affected devices for procedures requiring reprocessing until appropriate cleaning accessories and instructions are provided by the manufacturer.
The recalled product
- Product
- EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Affected units
- 1,014
Distribution
Distributed nationwide across the United States.
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