Recall Z-2565-2021— Olympus Corporation of the Americas

Name: FDA recall Z-2565-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-16

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-08-16, terminated 2024-03-11. It names one FDA 510(k) clearance: K023984. Product: BF-3C40 OES Bronchofiberscope, Model No. BF-3C40. Reason: 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.".

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2021-08-16
Terminated: 2024-03-11
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

BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

Reason for recall

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."

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