RecallRadar

FDA Device recall Z-2540-2017

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas…

On 2017-06-21 the FDA classified a Class II recall of Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas… by Cook, citing 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 reproce….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2540-2017
ClassificationClass II
Statusterminated
Initiated2017-05-03
Published2017-06-21
Last updated2026-09-13 11:54 UTC
CompanyCook
DistributionFL, IN, LA, MS, NC, TX, VA

Product

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

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.

Identifiers

code_info
Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2540-2017%22

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