Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. |
| Product | Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages |
| Quantity | 1328 units |
| Distribution | Domestic: FL IN LA MS NC TX Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom, VA/DOD:None |
| Initiated | 2017-05-03 |
| Classified | 2017-06-14 |
| Terminated | 2018-01-26 |
| Recall number | Z-2540-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-2540-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77305/
Alerts for COOK, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.