Data Foundry

Medical device recalls 2017

Vue Optic Visualization Source — Class II medical device recall Z-2540-2017

Terminated recall by Cook Inc., reported 2017-06-21, distributed in FL, IN, LA, MS, NC, TX. Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting

Recall numberZ-2540-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCook Inc., Bloomington, IN, United States
Recall initiated2017-05-03
Classified2017-06-14
Reported by FDA2017-06-21
Terminated2018-01-26
DistributedFL, IN, LA, MS, NC, TX
Countries outside the USAR, AU, BR, CA, CH, CZ, DE, EE, EG, ES, FR, GB, IL, IT, NL, NO, PL, PT, PY, TN, TR
Quantity1,328 units
Model numbersFV-090045-150, FV-090075-150, FVO-150, G25343, G34306, G50972

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2540-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.