Cook Inc. Recalls Vue Optic Endoscopes Due to Insufficient Reprocessing Instructions
Cook Inc. is voluntarily recalling Vue Optic Visualization Sources and Flexor Vue Deflecting Endoscopic Systems because current reprocessing instructions lack sufficient detail for cleaning and sterilization.
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 it is a voluntary recall initiated due to insufficient reprocessing instructions (documentation/labeling issue) rather than a reported defect causing injury or a high-risk pathogen. This aligns with the 'Moderate' criteria for minor labeling/documentation errors or voluntary precautionary recalls.
Plain-English summary
Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System. The recall was initiated because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
The affected products are fiber optic endoscopes supplied sterilized by ethylene oxide gas in peel-open packages. The specific catalog numbers involved are FVO-150, FV-090075-150, and FV-090045-150. A total of 1,328 units are included in this recall.
The products were distributed domestically in Florida, Indiana, Louisiana, Mississippi, North Carolina, and Texas, as well as in various foreign countries including Argentina, Australia, Brazil, Canada, and the United Kingdom. No VA/DOD distribution is reported. Users should stop using these devices and contact Cook Inc. for further instructions regarding the reprocessing documentation.
The recalled product
- Product
- Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Endoscope
- Affected units
- 1,328
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 (4)
- Vue Optic Visualization Source
- Catalog Number: FVO-150
- GPN: G50972 Catalog Number: FV-090045-150
- GPN: G34306
Distribution
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