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

Recall Z-2497-2021 — EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

U.S. FDA — Device Enforcement · United States · 2021-08-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2497-2021
Date of alert
2021-08-17
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: A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
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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