CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Vue Optic Visualization Source recalled by Cook

Cook is recalling Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber, distributed in Florida, Louisiana, Mississippi, North Carolina, Texas, Virginia. The recall was initiated on 3 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306

Quantity recalled1328 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2540-2017
FDA event ID: 77305
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 3 May 2017
FDA classified: 14 Jun 2017
Reported: 21 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

3 May 2017	Recall initiated by company
14 Jun 2017	Classified by FDA	+42 days
21 Jun 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

Where it was distributed

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

Florida Louisiana Mississippi North Carolina Texas Virginia

Questions about this recall

Is Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber recalled?

Yes. Cook recalled Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber on 3 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2540-2017.

Why was it recalled?

Which lots are affected?

Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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