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

Recall Z-2570-2021 — BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160

U.S. FDA — Device Enforcement · United States · 2021-08-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2570-2021
Date of alert
2021-08-16
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: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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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