Recall Z-2497-2021— Olympus Corporation of the Americas

Name: FDA recall Z-2497-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-17

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-08-17, terminated 2024-01-12. It names one FDA 510(k) clearance: K023984. Product: EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160. Reason: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2021-08-17
Terminated: 2024-01-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESThe Olympus Optical Co.·cleared 2003-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.