Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1718-2020 — Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds

U.S. FDA — Device Enforcement · United Kingdom · 2020-03-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1718-2020
Date of alert
2020-03-11
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Boddingtons Plastics Ltd
Product category
device
Product type
Devices
Reported risk: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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