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

Recall Z-0138-2017 — OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

U.S. FDA — Device Enforcement · United States · 2016-06-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0138-2017
Date of alert
2016-06-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Reported risk: New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
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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